CN110448407B

CN110448407B - Negative pressure wound closure device

Info

Publication number: CN110448407B
Application number: CN201910423336.1A
Authority: CN
Inventors: R.M.邓; E.Y.哈特维尔; V.J.哈蒙德; J.K.希克斯; E.M.哈德尔斯顿; A.凯莉; A.林顿; M.理查森; C.萨克斯比; T.斯特恩
Original assignee: University of Massachusetts UMass; Smith and Nephew Inc
Current assignee: University of Massachusetts UMass; Smith and Nephew Inc
Priority date: 2012-07-16
Filing date: 2013-07-16
Publication date: 2022-08-09
Anticipated expiration: 2033-07-16
Also published as: US20150190288A1; MX2015000715A; CN104812343A; CN104812343B; MX369689B; AU2013290346B2; AU2018226486A1; JP6824930B2; JP7346471B2; US9962295B2; US20190290495A1; AU2020201058A1; AU2020201058B2; JP2015524299A; EP2872085A1; WO2014014871A1; US10130520B2; AU2021261867A1; CA2879357C; US11083631B2

Abstract

The present invention relates to a negative pressure wound closure system and methods for using such a system. Preferred embodiments of the present invention facilitate wound closure by preferentially contracting to move tissue. Preferred embodiments are capable of applying a wound closure force to tissue using a tissue grasping element.

Description

Negative pressure wound closure device

The application is a divisional application of a PCT patent application (chinese national application No. 201380047782.8, international application No. PCT/US2013/050698, title of the invention "negative pressure wound closure device") which is filed on 13/3/2005 and has entered the chinese national phase.

Cross Reference to Related Applications

The present application claims the benefit of U.S. provisional application No.61/672,225 entitled "NEGATIVE PRESSURE WOUND CLOSURE DEVICE (NEGATIVE PRESSURE WOUND CLOSURE DEVICE)" filed on day 7, 16, 2012, U.S. provisional application No.61/771,732 entitled "NEGATIVE PRESSURE WOUND CLOSURE DEVICE" filed on day 3, 1, 2013, and U.S. provisional application No.61/780,629 entitled "NEGATIVE PRESSURE WOUND CLOSURE DEVICE" filed on day 3, 13, 2013. The contents of the above-identified application are hereby incorporated by reference in their entirety as if fully set forth in this specification. In accordance with the applicable law, the benefit of the priority of the aforementioned application is mandated, including but not limited to according to 35 u.s.c. § 119 (e).

Technical Field

Described herein are embodiments of devices, methods, and systems for treating wounds, particularly to assist in closing large wounds, in conjunction with the application of negative pressure.

Background

Negative pressure wound therapy is used in the treatment of wounds and in many cases is capable of increasing the rate of healing while also removing exudates and other harmful substances from the wound site.

Abdominal compartment syndrome, which results in a large increase in pressure within the abdominal cavity that may lead to organ failure and ultimately death, results from fluid accumulation in the abdominal cavity due to edema and other such causes. The etiology may involve sepsis or severe trauma. Treating abdominal compartment syndrome may necessitate an abdominal incision to permit decompression of the abdominal cavity, and therefore, may cause a large wound in the patient. This wound closure, while minimizing the risk of secondary infection and other complications, then becomes an urgent problem to resolve after the underlying edema has subsided.

Other large wounds or incision wounds resulting from surgery, trauma, or other conditions may also need to be closed. For example, wounds created by sternotomy, fasciotomy, and other abdominal wounds may need to be closed. Wound dehiscence in existing wounds is another possible complication that may arise from incomplete underlying fascia closure, or secondary factors such as infection.

Existing negative pressure treatment systems, while ultimately capable of wound closure, still require long closure times. While these negative pressure treatment systems may be used with other tissue fixation members, such as sutures, there may be a risk of the underlying muscle and fascia tissue not being properly re-approximated to permit complete closure of the wound. Moreover, when foam or other wound filler is inserted into a wound, the application of negative pressure to the wound and foam may cause atmospheric pressure to compress against the wound, compressing the foam downward and outward, against the edges of the wound. Such downward compression of the wound filler slows the healing process and slows or prevents the engagement of the wound edges. In addition, fascial inflammation in the form of certain types of fasciitis can result in rapid and excessive loss of tissue, potentially requiring a more advanced negative pressure treatment system. Accordingly, there is a need to provide improved devices, methods and systems for treating and closing wounds.

Disclosure of Invention

Embodiments of the present invention relate to negative pressure wound closure devices, methods, and systems that facilitate wound closure. The apparatus, methods and systems are operable to reduce the need for repeated replacement of currently used wound packing materials and can improve the rate of healing. The apparatus, methods, and systems may be used simultaneously with negative pressure to remove wound fluid.

In one embodiment, a wound closure device comprises:

a stabilizing structure comprising a plurality of planar support structures, each planar support structure comprising a first plurality of beams intersecting a second plurality of beams, the plurality of planar support structures arranged parallel to each other;

a plurality of spring elements engaging adjacent planar support structures, the plurality of spring elements for compressing the stabilization structure such that the planar support structures are closer to each other.

In some embodiments, the beam is rigid. In some embodiments, the first plurality of beams intersect the second plurality of beams at right angles. Some embodiments may provide that each planar support structure is substantially rigid in the plane of the support structure. In further embodiments, the planar support structure comprises one or more brackets located on an outer plane or perimeter. In further embodiments, the stent is provided with one or more tissue anchors configured to engage tissue placed in contact with the device. In some embodiments, the first plurality of spring elements lie in a first plane perpendicular to the planar support structure and the second plurality of spring elements lie in a second plane perpendicular to both the first plane and the planar support structure. Some embodiments may provide that the first plurality of spring elements lie in a first plurality of parallel planes that include the first plurality of stiffening beams, and wherein the second plurality of spring elements lie in a second plurality of parallel planes that include the second plurality of stiffening beams. Some embodiments may provide a spring element comprising a V-shaped member. In some embodiments, each planar support structure is identical. In some embodiments, a porous material, such as foam, surrounds one or more of the planar support structures. In further embodiments, the porous material surrounds the entire device. In some embodiments, the stabilizing structure comprises 2, 3, 4, 5 or more parallel planar support structures, with a spring element provided between each planar support structure. In some embodiments, there may be the same arrangement of spring elements between each of the planar support structures.

Another embodiment provides a stabilization structure comprising: a plurality of compartments arranged side-by-side in a plane, each compartment being defined by one or more walls, each compartment having a top end and a bottom end, an opening extending through the top and bottom ends in a direction perpendicular to the plane; wherein the stabilizing structure is configured to collapse more significantly within the plane than along a direction perpendicular to the plane.

In some embodiments, the stabilizing structure is constructed from a material selected from the group consisting of: silicone, polyurethane, flexible plastic, rigid plastic, and foam. In some embodiments, the compartments are identical; in other embodiments, one or more of the compartments are shaped differently than the remaining compartments. The plane may extend in a horizontal direction. In some embodiments, the wall may extend in a vertical direction. In some embodiments, the wall abuts an adjacent compartment. In some embodiments, the shape of each compartment is selected from the group consisting of: square, diamond, rectangular, oval and parallelepiped (parallelipiped). In some embodiments, at least one wall of each compartment comprises an indentation or hole. In some embodiments, at least one wall of each compartment is configured to fold against another wall of the compartment. Further embodiments may provide that each compartment is connected to an adjacent compartment by a junction, wherein the junction is more flexible than the wall. Some joints may be more flexible than other joints in the same compartment. The stabilizing structure may comprise compartments that are more collapsible along a first direction of the plane than along a second direction of the same plane that is at an angle to the first direction. Sometimes the second direction may be perpendicular to the first direction. The stabilizing structure may include a plurality of first strips extending in a first direction, and a plurality of intersecting strips extending in a second direction perpendicular to the first direction, wherein the structure is collapsible in the first and second directions.

In some embodiments, the one or more walls further comprise an insert disposed therein. The insert is more rigid than the one or more walls and may be inserted into a preformed pocket within the one or more walls. In some embodiments, the stabilizing structure comprises one or more inserts, and wherein each of the one or more walls is molded around a single insert. The insert may have a rectangular configuration. The insert may have a rectangular configuration with two dimples formed thereon. In some embodiments, the insert comprises one or more longitudinal grooves extending in the direction of the plane. The insert may also include one or more apertures disposed therethrough. In some embodiments, the holes are arranged in a 6x6 pattern. In certain embodiments, the holes are arranged in a 2x3 pattern or any other pattern. The one or more apertures may be provided on an edge of the insert.

Embodiments of the wound closure devices disclosed in this section or elsewhere in this specification may also include a porous material surrounding or within each compartment of the stabilizing structure described above and below. In some embodiments, the porous material may surround the entire stabilizing structure, or may surround only the perimeter of the stabilizing structure. The porous material may be a foam. In some embodiments, the porous material may surround or be within each compartment, quadrilateral space or other interior portion of the stabilizing structure. In some embodiments, the stabilizing structure may be inserted into a jacket (sock) or enclosure formed of a porous material such that the porous material covers at least a portion of the periphery of the stabilizing structure. In some embodiments, separate layers of porous material may be provided above, below, or on both the upper and lower layers of the stabilizing structure. In certain embodiments, the entire wound closure device or the entire stabilizing structure is surrounded by foam. In some embodiments, the compartment of the wound closure device may include an insert of foam or other porous material. In certain embodiments, the foam surrounds the perimeter of the stabilizing structure or wound closure device.

In other embodiments, a stabilizing structure sized for insertion into a wound includes:

at least one top strip extending in a first direction, the top strip including at least one indentation extending partially therethrough, and an opening on a bottom side of the top strip;

at least one bottom strip extending in a second direction, the bottom strip including at least one indentation extending partially therethrough, and an opening on a top side of the bottom strip;

wherein the at least one top and bottom strips are configured to be removably interlocked together by placing the indentation on the top strip over the indentation on the bottom strip, and

wherein at least one top strap and at least one bottom strap are configured to preferentially collapse along a first plane defined by the first and second directions while remaining movably interlocked and substantially non-collapsing along a third direction perpendicular to the first plane.

Further embodiments provide that the at least one indentation on the top strip and the at least one indentation on the bottom strip are sized such that, when movably interlocked together, the top strip does not extend substantially over the bottom strip in the third direction. In other embodiments, the stabilizing structure comprises at least two top strips and at least two bottom strips so as to form at least one quadrilateral space delimited by the two top strips and the two bottom strips.

In other embodiments, a stabilizing structure for insertion into a wound comprises:

at least one top strip extending in a first direction;

at least one bottom strip extending in a second direction;

wherein the at least one top strap and bottom strap are configured to be movably interlocked using an interlocking mechanism, and

wherein the at least one top strap and the at least one bottom strap are configured to preferentially collapse along a first plane defined by the first and second directions while remaining movably interlocked and substantially non-collapsing along a third direction perpendicular to the first plane.

In some embodiments, the interlock mechanism comprises: one of the at least one top strip or bottom strip comprising two parallel clasps extending in the third direction; the other of the at least one top strip or bottom strip comprising a protrusion extending in the third direction; and wherein the two parallel catches rotatably engage with the protrusion so as to rotate about the protrusion in the first plane while remaining substantially stationary in the third direction. In some embodiments, the interlock mechanism comprises: one of the top strap or the bottom strap comprising a projection having an enlarged distal end, the other of the top strap or the bottom strap comprising a cup-shaped member configured to receive the enlarged distal end of the projection therein; and wherein the top and bottom straps are rotatably engaged so as to rotate about the projection in the first plane without disengaging in the third direction. In some embodiments, the interlock mechanism comprises: one of the at least one top strap or bottom strap comprising four clasps disposed at a perpendicular angle to each other and extending in the third direction; the other of the at least one top strip or bottom strip comprises a protrusion extending in the third direction; and wherein two parallel clasps rotatably engage with the protrusion so as to rotate about the protrusion in the first plane while remaining substantially stationary in the third direction. Some embodiments may further comprise an uncompressed volume defined by a height of the stabilizing structure and an area of the stabilizing structure in the first plane when the first and second directions defined by the at least one top and bottom straps are at a perpendicular angle to each other, and wherein the stabilizing structure, when compressed, defines a compressed volume that is at least 15% less than the uncompressed area.

Further embodiments provide that the top strip includes at least one indentation extending partially therethrough and an opening on a bottom side of the top strip, and the bottom strip includes at least one indentation extending partially therethrough and an opening on a top side of the bottom strip. In such embodiments, the interlocking mechanism places the indentation on the top strip over the indentation on the bottom strip. In some embodiments, the at least one indentation on the top strip and the at least one indentation on the bottom strip are sized such that, when movably interlocked together, the top strip does not extend substantially over the bottom strip in the third direction. In other embodiments, the stabilizing structure comprises at least two top strips and at least two bottom strips so as to form at least one quadrilateral space delimited by the two top strips and the two bottom strips.

In some embodiments, there is provided a stabilizing structure for insertion into a wound, comprising: a plurality of elongate strips arranged in parallel (or generally parallel); and a plurality of intervening members connecting the elongate strips, wherein the plurality of intervening members are configured to pivot relative to the strips to allow the plurality of elongate strips to collapse relative to one another; wherein the intervening member between the first and second strips is configured to pivot independently of the intervening member between the second and third strips.

In certain embodiments, the intervening member is connected to the elongate strip via at least one joint. In certain embodiments, the joint is a hinge. In some embodiments, the hinge is configured to collapse in one direction. In certain embodiments, the joint is configured to limit movement of the intervening member. In certain embodiments, the elongate strips are rigid. In certain embodiments, the elongate strips are configured to bend along their length. In some embodiments, the elongate strips may be constructed of a material selected from the group consisting of: silicone, polyurethane, rigid plastic, semi-rigid plastic, biocompatible materials, flexible plastic materials, composites, and foams. In some embodiments, the intervening member is constructed of a material selected from the group consisting of: silicone, polyurethane, rigid plastic, semi-rigid plastic, biocompatible materials, flexible plastic materials, composites, and foams.

In some embodiments, the stabilizing structure includes a plurality of intervening members between adjacent elongate strips for defining a row of cells between each pair of adjacent elongate strips. In some embodiments, the compartments are diamond shaped. In certain embodiments, the cells in a row between adjacent elongate strips are configured to collapse together when the adjacent strips collapse relative to each other. In some embodiments, the row of cells between adjacent strips is configured to collapse in a first direction and the one or more rows of cells between adjacent strips are configured to collapse in a second direction opposite the first direction. In some embodiments, all of the row of cells of the stabilizing structure are configured to collapse in the same direction.

In some embodiments, the intervening member between the first and second strips is offset relative to the intervening member between the second and third strips. In certain embodiments, the foam surrounds the elongate strip and the intervening members. In some embodiments, foam is contained between adjacent elongate strips.

In certain embodiments, the intervening member comprises a panel. In other embodiments, the intervention member comprises: a plurality of bars configured to pivot relative to the elongate strips; and a plurality of pins connecting the elongate strips to the bar. In some embodiments, a plurality of stops are configured to limit rotational movement of the pin.

In other embodiments, the interventional member of the stabilizing structure described above may further comprise one or more sleeves and one or more inserts, wherein the sleeves are configured to receive the one or more inserts. In certain embodiments, the insert may be constructed of a rigid or semi-rigid material such as polyvinyl chloride. In some embodiments, the sleeve may be constructed of a flexible or semi-flexible material such as silicone or polyurethane. In other embodiments, the insert may also include one or more notches.

In some embodiments, the elongate strips of the stabilizing structure described above may include one or more flexing segments and one or more supporting segments. The flexing section may be constructed of a flexible or semi-flexible material such as silicone or polyurethane, while the support section may be constructed of a rigid or semi-rigid material such as polyvinyl chloride. In certain embodiments, the length of the support section is greater than the length of the flexure section.

In some embodiments, the elongate strip of the stabilizing structure described above may include apertures configured to allow fluid to pass therethrough. In further embodiments, the elongate strip may further comprise one or more gaps extending along at least a portion of the elongate strip. In other embodiments, the intervening members of the stabilizing structures described above may include one or more windows configured to allow passage of fluid. Other embodiments may provide a window that further includes a bar.

In certain embodiments, a stabilizing structure as described above may be configured such that 90% of the total collapse of any dimension occurs within one hour. In other embodiments, the stabilizing structure is configured such that 90% of the total collapse in any dimension occurs within five minutes.

Other embodiments may provide for the use of separate foam layers above, below, or on both the upper and lower layers of the stabilizing structure. In certain embodiments, the foam layer further comprises fingers that extend into or around the stabilizing structure. In some embodiments, the stabilizing structure is surrounded by foam in the form of a band or ring.

Embodiments disclosed in this section or elsewhere in this specification may also include a drape configured to be placed over the wound closure device or stabilizing structure once inserted into the wound to form a fluid-tight seal on the skin surrounding the wound. Embodiments may also include a negative pressure source configured to be connected to the wound and other related devices.

Other embodiments provide methods for closing a wound, comprising:

placing a wound closure device or stabilizing structure such as described in this section or elsewhere in this specification within a wound;

sealing the wound with a fluid-tight drape;

fluidly connecting the wound to a source of negative pressure; and

applying negative pressure to the wound via the negative pressure source.

Other embodiments may be used to remove fluid from a wound site. In some embodiments, the wound closure device or stabilizing structure is placed into the wound such that the direction of collapse or compression of the wound closure device or stabilizing structure is parallel or substantially parallel to the skin surface. In some embodiments, application of negative pressure may cause the wound closure device or stabilizing structure to at least partially collapse. Also, the wound closure device or stabilizing structure may be at least partially collapsed or compressed prior to insertion of the stabilizing structure into the wound. In some embodiments, the wound closure device or stabilizing structure is capable of collapsing or compressing to 40% or less, 30% or less, 20% or less, 10% or less, or even 5% or less of one of its original dimensions (e.g., one along its length). Some embodiments provide for a reduction in wound area of at least 50% after application of negative pressure.

Additional embodiments of the negative pressure wound closure system may include:

a stabilizing structure such as that described in this section or elsewhere in this specification;

a drape sized and configured to be placed over the stabilizing structure and form a substantially fluid-tight seal against an area of skin surrounding the wound; and

a source of negative pressure in fluid communication with the wound.

In certain embodiments, a method of closing a wound may comprise:

placing a wound closure device into a wound, the wound closure device configured to removably receive one or more inserts, wherein the wound closure device is configured to collapse under negative pressure;

sealing the wound with a fluid-tight drape;

fluidly connecting the wound to a source of negative pressure;

applying negative pressure to the wound via the negative pressure source; and

removing and/or inserting one or more inserts into the stabilizing structure to dynamically control collapse of the wound closure device.

Other embodiments of the above-described methods may provide a wound closure device including a stabilizing structure, such as a stabilizing structure including an interventional member, the interventional member further including one or more sleeves and one or more inserts, wherein the sleeves are configured to receive the one or more inserts, as described in this section or elsewhere in this specification.

Other embodiments of the wound closure device, stabilizing structure, and related apparatus are described below.

Drawings

Other features and advantages of the present invention will become apparent from the following detailed description of the invention when read in conjunction with the accompanying drawings, in which:

FIG. 1 illustrates an embodiment of a negative pressure processing system.

Fig. 2A-B are photographs before and after an experiment performed to determine the efficacy of an embodiment of a wound closure device.

Fig. 3A-D illustrate different views of an embodiment of a wound closure device including a stabilizing structure.

Fig. 4A-E illustrate different views and photographs of an embodiment of a wound closure device including a stabilization structure.

Fig. 5A-B, 6A-B, and 7A-B are photographs before and after an experiment performed to determine the efficacy of certain embodiments of wound closure devices.

Fig. 8A-E illustrate additional embodiments of wound closure devices including stabilizing structures.

Fig. 9A-C illustrate embodiments of stabilizing structures made from felted foam.

Fig. 10A-B are photographs of other embodiments of wound closure devices including porous wound filler material.

Fig. 11A-B, 12, 13, 14, 15, and 16A-B illustrate additional embodiments of wound closure devices including a stabilizing structure.

Fig. 17A-B, fig. 18A-B are photographs before and after an experiment performed to determine the efficacy of certain embodiments of wound closure devices.

Fig. 19 is a photograph of an experiment performed to determine the efficacy of certain embodiments of wound closure devices.

Fig. 20A-B are photographs of experiments performed to determine the efficacy of certain embodiments of wound closure devices.

Fig. 21A-E are photographs of various embodiments of a stabilization construct including an insert disposed therein.

Fig. 22A-F illustrate various embodiments of inserts that may be used in the stabilization construct.

Fig. 23A-F illustrate various views of an embodiment of a stabilization structure.

Fig. 24A-D illustrate various views of an embodiment of a stabilization structure.

Fig. 25A-E illustrate various views of an embodiment of a stabilization structure.

Fig. 26 schematically illustrates an embodiment of a stabilization structure.

FIG. 27A illustrates a top view of an embodiment of an elliptical stabilization structure.

Fig. 27B illustrates a top view of an embodiment of an elliptical stabilization structure provided with foam.

Fig. 28A-B illustrate an embodiment of a method for closing a wound.

Fig. 29A-C illustrate various views of an embodiment of a stabilization construct.

Fig. 30A-G illustrate various views of an embodiment of a stabilization structure.

Fig. 31 illustrates one embodiment of a hinged stabilizing structure for closing a wound.

Fig. 32 illustrates an embodiment of a fully flexible stabilization structure.

Fig. 33 illustrates one embodiment of a stabilizing structure for a wound.

Fig. 34 illustrates an embodiment of a stabilizing structure for a wound cut from a roll.

Fig. 35 illustrates an embodiment of a stabilization structure having an elliptical shape.

Fig. 36A-F illustrate various views of an embodiment of a stabilization structure.

Fig. 37A-D illustrate various views of an embodiment of a stabilization structure including openings for the passage of fluid.

Fig. 38A-C illustrate various embodiments of stabilization structures.

39A-B illustrate various embodiments of stabilizing structures including windows.

FIG. 40 is a photograph of one embodiment of a foam layer provided with fingers.

Fig. 41 is a photograph of an experiment for determining the efficacy of certain embodiments of a wound closure device.

Fig. 42A-C are photographs of various embodiments of a stabilization construct including a foam insert.

FIG. 43 illustrates an embodiment of a ring that may surround a stabilization structure.

FIG. 44 illustrates an embodiment provided with a stabilizing structure surrounding a ring and a foam layer.

Detailed Description

Embodiments disclosed in this section or elsewhere in this specification relate to apparatus and methods for treating wounds with reduced pressure, including pumps and wound dressing components and apparatus. In this section or elsewhere in this specification, devices and components including wound coverings and packing material (if any) are sometimes collectively referred to as dressings.

It should be understood that throughout this specification reference is made to a wound. It is to be understood that the term wound is to be understood in a broad sense and encompasses both open and closed wounds, where the skin is torn, cut or punctured or where trauma results in contusion, or any other epidermal or other condition or defect on the skin of a patient, or where it otherwise benefits from reduced pressure treatment. Thus, a wound is broadly defined as a damaged area of any tissue that may or may not produce fluid. Examples of such wounds include, but are not limited to, abdominal or other large or incisional wounds, dehiscent wounds, acute wounds, chronic wounds, subacute and dehiscent wounds, traumatic wounds, flaps and grafts, lacerations, abrasions, contusions, burns, electrical burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, trauma and venous ulcers, and the like, resulting from surgery, trauma, sternotomy, fasciotomy, or other conditions.

Reduced or negative pressure levels, such as-X mmHg, as used in this section or elsewhere in this specification, are pressure levels that represent pressures below a standard atmospheric pressure corresponding to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of-X mmHg reflects an absolute pressure of X mmHg lower than 760 mmHg, in other words, an absolute pressure of ((760-X) mmHg. additionally, a negative pressure that is "less than" or "less than" X mmHg corresponds to a pressure that is closer to atmospheric pressure ((e.g., -40 mmHg less than-60 mmHg), "more than" or "more than" -X mmHg corresponds to a pressure that is further from atmospheric pressure (e.g., -80 mmHg more than-60 mmHg).

The negative pressure range of some embodiments of the present disclosure may be approximately-80 mmHg, or between approximately-10 mmHg to-200 mmHg. Note that these pressures are relative to normal ambient atmospheric pressure. Thus, in a practical sense, -200 mmHg would be about 560 mmHg. In some embodiments, the pressure range may be between approximately-40 mmHg and-150 mmHg. Alternatively, pressure ranges up to-75 mmHg, up to-80 mmHg, or above-80 mmHg may be used. Also, in other embodiments, a pressure range of less than-75 mmHg may be used. Alternatively, the negative pressure device may supply a pressure range in excess of approximately-100 mmHg, or even-150 mmHg. In some embodiments, the negative pressure range may be as small as about-20 mmHg or about-25 mmHg, which may facilitate reduction of fistulae. In some embodiments of the wound closure devices described herein, increased wound contraction may result in increased tissue expansion in the surrounding wound tissue. This effect may be increased by varying the force applied to the tissue, for example by varying the negative pressure applied to the wound over time, possibly in conjunction with increasing the tension applied to the wound via embodiments of the wound closure device. In some embodiments, the negative pressure may be varied over time, for example using a sine wave, a square wave, and/or in synchronization with one or more patient physiological indicators (e.g., heart beat). Examples of such applications may be found in connection with the foregoing, including application serial No. 11/919,355 entitled "Wound treatment device and method" (published as US 2009/0306609) filed on 26.10.2007, and U.S. patent No. 7,753,894 entitled "Wound cleansing device with stress" published on 13.7.2010. Both of these applications are incorporated herein by reference in their entirety. Other applications that may contain relevant teachings for use with embodiments described in this section or elsewhere in this specification may include: an application having serial number 12/886,088 entitled "System And method For managing Open Abdominal Wounds Using Negative Pressure Wound Therapy" (published as US 2011/0213287), filed on 9, 20, 2010; an application entitled "Wound Dressing And Method Of Use" (published as US 2011/0282309) filed on 21.4.2011 under the name Of 13/092,042; and an application serial No. 13/365,615 entitled "Negative Pressure Wound Closure Device" (published as US 2012/0209227) filed on 3/2/2012.

It should be understood that throughout this specification, reference will be made to elongate, elongate or longitudinal strip(s) in some embodiments. It should be understood that these terms are to be interpreted broadly, and in some embodiments refer to an elongate material having two parallel or substantially parallel faces, wherein in cross-section the thickness of the material measured perpendicular to the faces is relatively less than the height of the material measured parallel to the faces. While in some embodiments the strips may be constructed of discrete lengths of material, in other embodiments the strips may be elongate portions of an overall structure having two parallel or substantially parallel faces. In some embodiments, the strips have faces that are rectangular or generally rectangular in shape, with the length of the face being greater than the height of the face. In some embodiments, the length of the face may be greater than 2, 4, 6, 8, or 10 times greater than the height of the face.

The term "horizontal" as used in this section or elsewhere in this specification, when referring to a wound, is meant to refer to a direction or plane that is generally parallel to the skin surrounding the wound. The term "vertical" when referring to a wound generally refers to a direction extending perpendicular to a horizontal plane. The term "longitudinal" when referring to a wound generally refers to a direction in a horizontal plane taken along the longest direction of the wound. The term "transverse" when referring to a wound generally refers to a direction in a horizontal plane perpendicular to the longitudinal direction. The terms "horizontal", "vertical", "longitudinal" and "transverse" may also be used to describe the stabilizing structure and wound closure device described throughout this specification. When describing these structures or devices, these terms should not be understood as requiring that the structures or devices must be placed into the wound in a certain orientation, but in certain embodiments, it may be preferable to be placed into the wound in a certain orientation.

Fig. 1 illustrates an embodiment of a negative pressure treatment system 100, the negative pressure treatment system 100 including a wound packing 102 inserted into a wound 101. The wound packing 102 may comprise a porous material such as foam, and in some embodiments, the wound packing 102 may comprise one or more embodiments of a wound closure device described in more detail in this section or elsewhere in this specification. In some embodiments, the perimeter or top of any wound closure device inserted into wound 101 may also be covered with foam or other porous material. A single drape 104 or a plurality of drapes may be placed over the wound 101 and preferably adhered or sealed to the skin around the wound 101 to form a fluid tight sealAnd (4) sealing. The aperture 106 may be made through the drape 104, and the aperture 106 may be made manually or pre-formed into the drape 104 to provide a fluidic connection from the wound 101 to a source of negative pressure, such as a pump 110. Preferably, the fluidic connection between the aperture 106 and the pump 110 is formed via a conduit 108. In some embodiments, the catheter 108 may include Smith&RENASYS Soft Port made by Nephew ^TM . Of course, in some embodiments, the cover towel 104 may not necessarily include the aperture 106, and the fluid connection to the pump 110 may be made by placing the conduit 108 under the cover towel. In some wounds, particularly in larger wounds, a plurality of conduits 108 fluidly connected via one or more apertures 106 may be used.

In some embodiments, the drape 104 may be provided with one or more wrinkles or folds. Preferably, the wrinkles are aligned along the longitudinal axis of the wound and may thus support wound closure by preferentially collapsing in a direction perpendicular to the longitudinal axis of the wound. Such wrinkles may help apply contraction forces parallel to the wound surface and in the wound closing direction. An example of such a drape may be found in an application entitled "Vacuum Closure Device" (published as US 2011/0054365) filed 11/17/2010 under serial No. 12/922,118, which is incorporated herein by reference in its entirety.

In use, the wound 101 is prepared and cleaned. In some cases, such as in abdominal wounds, a non-adherent or very low-adherent organ protective layer (not illustrated) may be applied over any exposed viscera. The wound packing 102 is then inserted into the wound and the wound packing 102 is covered with a drape 104 to form a fluid tight seal. The first end of the conduit 108 is then placed in fluid communication with the wound, such as via the aperture 106. The second end of the conduit 108 is connected to a pump 110. The pump 110 may then be activated to supply negative pressure to the wound 101 and drain wound exudate from the wound 101. As will be described in more detail below with respect to embodiments of the aforementioned wound closure device, the negative pressure may also help promote wound 101 closure, for example by causing opposing wound edges to re-approximate.

Example 1

By way of non-limiting example, an experiment was performed to determine the utility of the embodiments of the wound closure device described above, with the test being performed on a cadaver model. A midline incision is made through the peritoneum into the cadaveric abdominal cavity, which is then filled with two saline bags, of a total capacity of approximately 2L, to provide an upward tension simulating the effects of abdominal edema and organ distension (as may be seen in the case of celiac syndrome). These bags were placed along with the gut into a wound cavity beneath the organ protection layer provided in Renasys a/B process kit (Smith & Nephew).

Referring to fig. 2A, a piece of black foam is inserted into the abdominal incision, sealed with a drape, and connected to a negative pressure source via a fluidic connection (here, a Soft Port suction Port assembly manufactured by Smith & Nephew). Fig. 2B illustrates the area of the wound after activation of the negative pressure source. Negative pressure was then applied at 80, 120 and 180 mmHg. With all three negative pressure levels, there was no significant difference in the amount of wound edge contraction achieved, but vacuum levels below 80 mmHg did not appear to contract the wound edge as much. This is always true in all other subsequent experiments described in this section or elsewhere in this specification.

Wound area measurements were taken before and after activation of the negative pressure source. In this example, the wound area size is 167 mm from before negative pressure is applied ² Reduced to 126 mm after application of negative pressure ² . This difference was 25%.

Stabilizing structure and wound closure device of fig. 3A-4E

Fig. 3A-D illustrate different views of an embodiment of a wound closure device including a stabilization structure 1701. Here, the stabilizing structure 1701 comprises a first set of beams 1703, the first set of beams 1703 being rigidly or semi-rigidly attached or bonded to a second set of intersecting beams 1705. These

beams

1703, 1705 form a planar support structure 1702, the planar support structure 1702 preferably being substantially rigid in a plane. The

beams

1703, 1705 may meet at right angles to each other (although other configurations, such as honeycomb type, are also possible). Two or more planar support structures 1702 may be joined together to form stabilization structure 1701, and each planar support structure 1702 is preferably separated from each other by

spring elements

1711 and 1713, as described in more detail below. The number of planar support structures 1702 used in the stabilization structure can be adjusted relative to the wound size. For example, there may be 2, 3, 4, 5, or more planar support structures 1702 arranged parallel or substantially parallel to each other.

Spring elements

1711, 1713 are preferably arranged to allow stabilization structure 1701 to compress in a direction so as to bring planar support structures 1702 closer together. In a preferred embodiment, the stabilizing structure 1701 may collapse to 40% or less of its original size, preferably to 30% or less of its original size; more preferably, to 20% or less of its original size; even more preferably, to 10% or less of its original size. In some embodiments, the stabilizing structure 1701 may collapse to 5% or less of its original size.

The

spring elements

1711, 1713 are preferably resiliently flexible and biased to resiliently collapse in a direction perpendicular to the plane defined by the planar support structure 1702. In some embodiments, the

elements

1711, 1713 may be inelastic and retain their shape when collapsed. In these embodiments, the spring elements or stabilizing structures may be configured with a ratchet mechanism that maintains the

spring elements

1711, 1713 in their collapsed configuration.

In a preferred embodiment, these

spring elements

1711, 1713 may be V-shaped or U-shaped. Each spring member may include two elongated portions that are bent relative to each other and form an obtuse angle (as shown in fig. 3A-3C) or an acute angle (as shown in fig. 4A). The spring element 1711 preferably extends in a plane parallel to the beam 1705 and may be attached to the

beam

1703 or 1705. Similarly, the spring element 1713 preferably extends in a plane parallel to the beam 1703, and may be attached to the

beam

1703 or 1705. For both

spring elements

1711, 1713, it is preferred that the attachment point is at the intersection between the

beams

1703 and 1705. PreferablyThe spring elements 1711 are arranged in a first plurality of parallel planes that extend parallel to the direction of the beam 1705, and the spring elements 1713 are arranged in a second plurality of parallel planes that extend parallel to the direction of the beam 1703. Spring elements 1711 located between two adjacent planar support structures 1702 may be arranged in a repeating pattern in a first plurality of parallel planes. Spring elements 1713 located between two adjacent planar support structures 1702 may be arranged in a repeating pattern in a second plurality of parallel planes. In one embodiment illustrated in fig. 3A and 3C,

adjacent spring elements

1711 and 1713 form a diamond shape. However, different patterns, arrangements and numbers of spring elements may be used. In some embodiments, the

spring elements

1711, 1713 may have a spring constant in a range between 10 and 30N/m, more preferably between 15 and 25N/m, and even more preferably a spring constant of 23N/m. In some preferred embodiments, the force necessary to compress seven spring elements 15 mm is equal to 250 g. In some embodiments, the amount of force necessary to compress the same seven springs the same distance ranges between 180 and 230 g. In some embodiments, there are a total of four

spring elements

1711, 1713, each 10 cm ³ . Of course, it will be appreciated that factors such as spring constant and/or number of springs may be adjusted depending on the particular tissue type and wound closure desired, and higher or lower spring constants or numbers of springs may be used.

Braces

1707 and 1708 may be provided at the edge of the structure 1701 or along the exterior face of the structure 1701 and may be configured to contact the wound. In some embodiments, the

supports

1707, 1708 may be extensions of the

beams

1703, 1705, or these supports may be provided separately. In some embodiments, the

stents

1707, 1708 may be provided with hooks or anchoring elements configured to anchor tissue placed in contact therewith. Additionally or alternatively, hooks or anchoring elements attached to the structure 1701 may be provided separately from the

supports

1707, 1708, or in place of the

supports

1707, 1708. These hooks or anchoring elements can be used to enhance the closure of the fascia tissue by ensuring that the closure velocity of the different tissue layers (e.g., muscle tissue, adipose tissue) is approximately the same. Preferably, the hooks or anchoring elements are configured to have a release force (once engaged into tissue) that causes little or no pain to the patient while permitting sufficient pulling force to be applied to the patient to allow the wound to close. In some embodiments, different anchoring elements may be used to engage different types of tissue. For example, the release force used to release an anchoring element from subcutaneous adipose tissue may be lower than the force required to release another anchoring element from muscle tissue.

Also, the anchor element, by virtue of its attachment to the surrounding tissue, may be used to help prevent a drape or other material placed over the wound from entering the edge between the skin and the structure 1701. In some embodiments, the anchoring elements may be detachable, which may help adjust the size of the device to fit into the wound as described below. Additionally, all or a portion of structure 1701 may be covered by or embedded within a porous wound packing material. In these configurations, the

braces

1707, 1708 may be used to provide additional securement to any such wound filler material.

In use, the stabilization structure 1701 may be cut to a size suitable for mating with a wound. Optionally, a porous material, such as foam, may be placed around the perimeter of the structure 1701 and may be secured using one or more of the

brackets

1707, 1708. The porous material may also surround or encapsulate the entire apparatus, for example by using a foam envelope. Foam may also be added to the entire structure 1701, including the interior portions of structure 1701, and structure 1701 is preferably capable of undergoing a web forming process if this process is performed during the manufacturing process. Such devices comprising foam will have a composite stretch structure that is considered when inserting the device into a wound. When inserting the device into a wound, the stabilizing structures 1701 are preferably oriented such that the planar support structures 1702 are aligned such that these planar support structures 1702 are perpendicular or substantially perpendicular to the general direction of wound closure, or perpendicular or substantially perpendicular to the skin of the patient. Optionally, an organ protection layer (which may comprise a polymer sheet or other flexible material, optionally provided with apertures) may be placed in contact with at least a bottom portion of the wound. A drape may be sealed to the skin surrounding the wound and a source of negative pressure may be placed in fluid communication with the wound to effect wound closure. Further details regarding the drape, application of negative pressure, and other devices and methods that may be used with these stabilizing structures are described below with respect to other embodiments.

Fig. 4A-E illustrate different views and photographs of an embodiment of a wound closure device including a stabilizing structure 1201. Some aspects and functions of this embodiment are similar to the embodiment described above with respect to fig. 3A-D, and all have similar elements. The apparatus includes

beams

1203 and 1205,

beams

1203 and 1205 forming a planar support structure 1202, planar support structure 1202 being separated by

spring elements

1211 and 1213.

Brackets

1207 and 1208 may also be provided. Here, however, the

spring elements

1211 and 1213 are thicker and have portions that are bent at an acute angle with respect to each other. In addition, the structure 1201 is more bulky and the number of

spring elements

1211, 1213 is greater compared to fig. 3A-D. As best illustrated in FIG. 4D, the spring elements 1211 form a repeating diamond-shaped pattern in a first plurality of parallel planes, the diamond-shaped locations being staggered between adjacent parallel planes. The spring elements 1213 in the second plurality of parallel planes use a corresponding pattern. A similar configuration can be seen in fig. 3A-3D.

Example 2

By way of non-limiting example, an experiment was performed to determine the utility of the embodiments of the wound closure device described above, with the test being performed on a cadaver model. Figures 5A-B illustrate the results of placing a structure provided with foam, similar to the embodiment of figures 4A-E, into a wound. The perimeter of the structure is encased in a layer of foam.

Wound area measurements before and after application of negative pressure showed a 64% reduction in wound area from 152 mm ² Reduced to 55 mm ² 。

Example 3

The structure tested in this non-limiting experiment was encased in foam and pre-stretched across its width and held in place by bendable plastic strips, but otherwise similar to the embodiment of fig. 4A-E. Fig. 6A-B illustrate wound size before and after application of negative pressure. Here, the measurement of the wound area is 154 mm before applying negative pressure ² And after that is 101 mm ² The wound area was reduced by 34%.

Example 4

Figures 7A-B illustrate non-limiting results of experiments in which a structure similar to the embodiment of figures 4A-E was placed into a wound and without any foam wrapping. The experiment was performed in a manner similar to the other examples described in this section or elsewhere in this specification, and here the measurement of wound area was 126 mm before negative pressure was applied ² And after that 53 mm ² The wound area was reduced by 58%.

8A-16B, 19-20B, and 32

Fig. 8A-E illustrate additional embodiments of wound closure devices including a stabilization structure 1100. Fig. 8A illustrates a perspective view of an embodiment of a stabilization structure 1100. Here, the stabilizing structure 1100 is preferably comprised of two or more interlocking strips (described in more detail below with respect to fig. 8B) that extend in directions that are generally perpendicular to each other when in a substantially uncollapsed configuration. The stabilizing structure is preferably configured to collapse in one direction, or along a first plane, while remaining relatively rigid and resistant to collapse in a direction perpendicular to the first direction or plane.

Fig. 8B illustrates a side view of a bottom strip 1102 and a top strip 1104 that may be used to fabricate a stabilization structure 1100, such as the embodiment illustrated in fig. 8A. Each of the top strap 1102 and the bottom strap 1104 are preferably configured to removably interlock with each other, such as via

mating indentations

1106 and 1108. One or more indentations 1106 may be provided on the top side of the bottom strip 1102 and similarly, one or more indentations 1108 may be provided on the bottom side of the top strip 1104. When assembled together, the one or more top and

bottom straps

1102, 1104 may be positioned such that the

indentations

1106, 1108 are aligned. Preferably, the top strap 1102 and the bottom strap 1104 are positioned at a substantially perpendicular angle to each other, thereby permitting the

indentations

1106, 1108 to be inserted together to form a movably interlocking structure. Typically, the number of indentations 1106 on the bottom strip 1102 will equal the number of top strips 1108 that will form the stabilization structure 1100, and vice versa. The shape of the

indentations

1106, 1108 is preferably designed to have a width that permits the

straps

1102, 1104 to move from an angle that is approximately perpendicular to each other to an angle that is away from perpendicular (i.e., nearly parallel) to each other, thus permitting the stabilization structure 1100 to articulate and collapse in one direction or plane.

In a preferred embodiment, the

strips

1102, 1104 are constructed of a rigid or semi-rigid material, such as a polymer. Examples of suitable polymers include polyethylene, polypropylene, polyurethane, polyvinyl chloride, polystyrene, polyacrylate, polymethyl methacrylate, PEEK, silicone, polyurethane, polycarbonate, composites and laminates or combinations thereof. In some embodiments, the material may comprise compressed or "felted" (filtered) reticulated foam. Of course, other materials, such as cardboard or metal, may also be used. Preferably, the materials may be at least partially porous so as to permit fluid flow through the material. Moreover, these properties may help distribute negative pressure through the device and to the wound, and may help remove fluids from the wound dressing. Such materials may comprise, for example, low density polypropylene, foam or sintered materials. The material used does not necessarily need to be strong along the length of the

strips

1102, 1104, but should preferably be able to withstand the pressure applied to the top or bottom edges. Preferably, the material is capable of withstanding pressure from atmospheric pressure applied to the drape when a negative pressure of up to 200 mmHg is applied to the wound. In some embodiments, the material is capable of withstanding a force of 5 psi applied to the top edge or the bottom edge.

In a preferred embodiment, the dimensions of each

strip

1102, 1104 are 180 mm long by 30 mm high. The thickness of the

strips

1102, 1104 may range, for example, between 1.50 and 2.40 mm, but will be selected at least in part according to the ability of the material to withstand pressure applied along its edges. The thickness is preferably balanced between: keeping the material thin enough minimizes the compressed thickness of the stabilization structure 1000 while keeping the material thick enough can avoid excessive local pressure on the wound surface. The height of the

indentations

1106, 1108 may be approximately 15 mm and may be spaced 18 mm from the other indentations. Although the

dimples

1106, 1108 are shown as having rounded bases, they can also be cut to have square or triangular bases. In some embodiments, rounded edges can reduce stress on the

strips

1102, 1104 to prevent crack and fracture propagation, and can also increase the spring force of the stabilization structure 1100.

It should be understood that the interlocking

strips

1102, 1104 may not necessarily need to be joined together via dimples. Hinges or other devices may be used to provide the articulation or movable interlocking capabilities illustrated above. In some embodiments, the hinge may be constructed from thinner regions of the same material from which the

strips

1102, 1104 are constructed and configured to flex or bend to a predetermined position. The stabilization structure 1100 may also be molded as a single piece such that the interlocking

strips

1102, 1104 form a single unit.

Referring back to fig. 8A, this perspective view illustrates an example of a configuration of a stabilization structure 1100 provided with a plurality of interlocking top and

bottom straps

1102, 1104, the top and

bottom straps

1102, 1104 being movably interlocked via a plurality of

indentations

1106, 1108. The intersection of the two top strips 1102 and the two bottom strips 1104 form a quadrilateral bounded space 1109. When the top strap 1102 and the bottom strap 1104 are at a perpendicular angle to each other, the space 1109 will be square or rectangular. However, when the stabilizing structure 1100 collapses in one direction or plane, the space 1109 will become more diamond-shaped or parallelogram-shaped. The stabilizing structure 1100 will preferably include a plurality of spaces 1109, the spaces 1109 forming compartments that are defined by the walls of the top and bottom straps and that are provided with openings at the top and bottom ends of the compartments.

Fig. 8C illustrates a top view of an embodiment of a stabilization structure 1100 in which a porous wound filler material 1110 has been placed into the spaces 1109 of the quadrilateral boundary. Here, the porous wound filler material 1110 used is preferably soft and conformal so as to be able to accommodate any changes in the configuration of the stabilizing structure 1100 in the event that the stabilizing structure 1100 collapses. Preferably, the porous wound filler material is a foam, such as a polyurethane foam. This porous wound filler material may be cast around the stabilization structure 1100 to completely encapsulate the stabilization structure 1100. In use, the resulting stabilization structure 1100 may be cut to size to fit into a wound. Such porous wound filler material 1110 may be used to help transport or wick fluids from within the wound, and may also help with wound healing when in contact with the wound (e.g., when used in negative pressure wound therapy).

Fig. 8D illustrates a perspective view of an embodiment of the stabilization structure 1100 with a porous wound filler material 1110 inserted into the space 1109. In some embodiments, additional porous wound filler material may also be used to encapsulate or surround the structure 1100. For example, a sheath or wrap may be fitted around the structure 1100 and constructed, for example, from foam or gauze. When inserted into a wound, the stabilizing structure 1100 may preferably be oriented to collapse in a direction generally parallel to collagen and other fibrous tissue fibers in the body. This orientation is sometimes referred to as the langasite or kraisl's lines, and closing a wound in a direction coincident with (and preferably parallel to) these lines may be faster and easier to heal than attempting to close a wound in a direction perpendicular or opposite to these lines. It should be understood that other embodiments of the stabilizing structure described in this specification may be oriented in the same manner with respect to a Langerhans-type line or a Cruis-type line or other indicia.

Advantageously, for some types of wounds, the stabilizing structure of fig. 8A may be elongated in a direction perpendicular to the primary closing direction, but still in the horizontal plane. Such elongation may be beneficial for wound healing, as the physiology of the wound may dictate that the wound should lengthen upon closure.

In use, the stabilizing structure 1100 may be placed into a wound such that the upwardly facing portion of the structure 1100 is substantially rigid and resists collapsing in a vertical direction upon application of negative pressure to the wound (e.g., upon being covered by a drape as previously described). A porous material, such as foam, may be placed around the stabilization structure 1100, into the stabilization structure 1100, and/or surround or encapsulate the stabilization structure 1100. In some embodiments, an organ protection layer as previously described may be placed in contact with at least a bottom portion of the wound. When negative pressure is applied, the structure 1100 will then preferably collapse in a plane perpendicular to the vertical direction, thereby assisting in wound closure. Due to the relative incompressibility of the device in the vertical dimension, the pressure transmitted from the greater atmospheric pressure to the wound placed on the drape will result in a reduction in the pressure applied to the stabilizing structure 1100 and thus to the wound edge, as compared to prior art devices such as those illustrated in fig. 2A-B. Optionally, in this and other embodiments described in this section or elsewhere in this specification, negative pressure may be applied to increase the transmission of negative pressure to the sides of the wound rather than to the bottom portion of the wound. This effect can be achieved, for example, by providing an organ protection layer which at least partially shields the wound base from the negative pressure. In a preferred embodiment, a negative pressure of at least 100 mmHg, preferably 120 mmHg, 140 mmHg, 180 mmHg or 200 mmHg will be provided to the sides of the wound, while a negative pressure of at most 120 mmHg, more preferably 80 mmHg, 40 mmHg, 20 mmHg or 10 mmHg will be provided to the bottom of the wound.

Fig. 8E illustrates a CT image of the embodiment of the stabilization structure 1100 illustrated in fig. 8A-D, the stabilization structure 1100 being inserted into an abdominal wound. The tissue fascia layer is also visible, with the subcutaneous fat layer 1190 overlying the muscular tissue layer 1192. After application of negative pressure (as illustrated), improved re-approximation of the fascia and wound closure can be observed. Specifically, the layers of muscular tissue 1192 on opposite sides of the wound have moved much closer together while remaining attached to the other layers of fascia. In terms of measuring size, the width of the wound along the illustrated view is reduced from approximately 82 mm to 28 mm, a 65% reduction.

Fig. 9A-C illustrate an embodiment of a wound closure device including a stabilizing structure 1100, the stabilizing structure 1100 being similar to the stabilizing structure described above with respect to fig. 8A-E. Here, the stabilization structure 1100 is constructed from interlocking strips of felt foam construction. The physical relationship between top strap 1102 and bottom strap 1104, and the mechanism for interlocking top strap 1102 and bottom strap 1104, are substantially similar to the discussion above and will not be repeated here. However, a felted foam is a foam (e.g., a polyurethane foam) that has been heated and compressed. After this procedure, the foam will be stiffer and less compressible while still being porous. Such materials may be advantageously used in a stabilizing structure 1100 for a wound closure device because such materials may be compressible in the plane defined by the top and

bottom strips

1102, 1104, as shown in fig. 9B. However, this material is substantially rigid in the vertical direction, as illustrated in fig. 9C, where weight placed on the foam does not substantially collapse. Here, the foam was able to support a weight of approximately 6 kg, and embodiments of the device were measured to be able to support an applied pressure of at least 3 psi without collapsing. Moreover, while such materials are substantially rigid, the materials, by virtue of their porous nature, permit the transmission of negative pressure to the wound and the removal of wound exudate.

Fig. 10A-B are photographs of other embodiments of wound closure devices. Fig. 10A illustrates an embodiment of a wound closure device 1301 that preferentially collapses in one direction. Here, wound closure device 1301 comprises a porous wound filler material (e.g., foam) in which one or more grooves 1303 have been cut. These grooves 1303 preferably extend longitudinally through the thickness of the wound closure device 1301. Thus, when a force is applied in a direction perpendicular to the recess 1303, this empty space will permit the wound closure device to preferentially collapse in one direction. Because this empty space is more easily compressed than the rest of the foam, the width and thickness of the foam will preferably not be compressed (or compress very little) compared to the compression created perpendicular to the length of the wound closure device 1301.

As illustrated in fig. 10B, wound closure device 1301 may also be provided with apertures or compartments 1305 in other configurations, such as diamond shaped apertures forming a grid. This configuration permits compression along the length and width of the wound closure device due to the compressible aperture 1305, while the relatively rigid, greater thickness of the foam resists compression to a greater extent.

In some embodiments, some stabilization structures similar to the stabilization structure illustrated in fig. 8A-E above may be constructed as a single unit (e.g., by molding), rather than constructed from multiple parts. As with the previously described embodiments, the stabilizing structure is configured to form an array of one or more compartments defined by one or more walls and forming a plane, wherein the top and bottom ends of each compartment are provided with an opening extending through the top and bottom ends in a direction perpendicular to the plane. In some embodiments, these stabilizing structures may be provided with square, diamond, rectangular, oval, diamond, and/or parallelepiped compartments, and non-limiting examples of these stabilizing structures are illustrated in fig. 11-20. While the shape of the compartments of some embodiments may all be the same, the compartments may also be adjusted to be larger, smaller, or of a different shape than the other compartments in the structure. The shape and size of the compartments (e.g., elasticity and ease of collapse) may be adjusted according to the desired characteristics in order to achieve optimal wound closure and healing.

Constructing a single unit stable structure may be advantageous in terms of ease of use and cost. For example, the stabilizing structure of the individual units may be adjusted as necessary to fit into the wound site. The materials used are preferably biocompatible and even more preferably do not adhere to the wound site. Suitable materials are preferably selected to be soft while still being strong enough to resist collapse in the vertical direction, and may comprise polymers such as polyethylene, polypropylene, polyurethane, silicone (including siloxanes), vinyl acetate, and copolymers and mixtures thereof. The stiffness of the material may affect the thickness of the resulting stabilizing structure, and may be selected based on the desired thickness of the stabilizing structure components (including its hinges and other joints) and the ability of the stabilizing structure to resist collapse, e.g., due to atmospheric pressure acting on a drape placed over the stabilizing structure. Suitable durometer hardnesses for the materials used range from about 30 to 120 shore (measured on the shore a durometer scale), preferably from about 40 to 60 shore, and even more preferably about 42 shore. In general, the material selected is preferably softer (while still satisfactorily meeting other material requirements) because as the hardness increases, the degree of closure provided by harder materials may decrease.

Fig. 19 is a photograph of an embodiment of such an apparatus 1100 configured as a single unit. The pores 1109 are filled with a porous material 1110, and in some embodiments, the porous material 1110 may include foam. Here, device 1100 is inserted into a wound.

Fig. 11A-B illustrate an embodiment of a stabilizing structure 1100, the stabilizing structure 1100 configured to preferentially collapse in only one horizontal direction while remaining substantially rigid or non-collapsing when a force is applied in a vertical direction. Preferably, the stabilizing structure 1100 is configured as a single unit as illustrated to form one or more compartments 1131. Here, two or more longitudinal strips 1120 (these longitudinal strips 1120 form the walls of the compartment) may have a relatively straight configuration and are connected together via one or more collapsible cross-strips 1122. It should be understood that in the single cell embodiment, the strips are merely portions of the same material that may be formed together to form the entire single cell structure. The collapsible cross-strips 1122 may be angled or serrated to make them more likely to collapse in a direction generally parallel to their length. In this embodiment illustrated in this section or elsewhere in this specification, the collapsible cross-strips 1122 are more likely to collapse at the apex of the angle-bent out section and at the intersection with the longitudinal strips 1120 when a force is applied in a direction generally parallel to the overall length of the collapsible cross-strips 1122. In some embodiments, the collapsible cross-over strips are configured to fold into a portion of the longitudinal cross-over strips 1120 (which may be thinner).

In some configurations, one or both of the longitudinal strips 1120 and/or the collapsible cross-strips 1122 may include one or more indentations positioned along its length. These indentations facilitate the transfer of fluid across the structure and help distribute negative pressure. In some embodiments, indentations may be used with the porous material to enhance fluid transfer. The collapsible cross-strips 1122 may be positioned alternately (as most clearly illustrated in fig. 11B) along the length of the longitudinal strips 1120 relative to the longitudinal strips 1120 to form a configuration somewhat similar to the "staggered joint" used when laying bricks. Of course, other configurations are possible. Also, while this embodiment is illustrated as being formed as a single unit, those skilled in the art will recognize that this embodiment (and others described below) may be constructed from multiple parts joined or connected together.

Fig. 20A-B are photographs of an embodiment of a stabilization structure 1100, the stabilization structure 1100 being similar to one of the stabilization structures described above with respect to fig. 11A-B. Here, the structure 1100 is inserted into the wound 1140 and placed under the drape 1145. The negative pressure source is connected via a fluid connection 1150. Fig. 20B is a close-up view of the stabilization structure 1100 taken in fig. 20A, illustrating how the compartments 1131 collapse under the cover wipes 1145 when negative pressure is applied. An optional porous wound filler 1148 is also illustrated.

Fig. 12 illustrates another embodiment of a stabilizing structure 1100, here comprising two or more longitudinal strips 1120, the longitudinal strips 1120 being attached to each other via one or more angled cross-strips 1124 to form a compartment 1131. As with the embodiment illustrated in the previous figures, the stabilizing structure 1100 is configured to collapse when pushed in a direction perpendicular to the length of the longitudinal strips 1120, while the stabilizing structure 1100 remains substantially rigid or does not collapse when a force is applied in a vertical direction. The angled intersecting strips 1124 are preferably attached to the longitudinal strips 1120 so as to form a non-perpendicular angle, thereby facilitating collapse of the stabilizing structure 1100 in a direction perpendicular to the length of the longitudinal strips 1120. As with fig. 8A-B, one or more indentations can be formed on either or both of the longitudinal strips 1120 and/or the angled cross-strips 1124.

Fig. 13 illustrates a single-unit stabilization structure 1100 that includes one or more pairs of curved longitudinal strips 1126. Each individual longitudinal strip 1126 may be formed as an "undulating" strip (when viewed from a vertical orientation) that, when joined face-to-face, form one or more circular or oval compartments 1127. As with other stabilizing structures illustrated in this section or elsewhere in this specification, this structure 1100 is configured to collapse, preferably along a horizontal plane or direction, while remaining substantially rigid or not collapsing when a force is applied in a vertical direction. Although the structure 1100 is illustrated herein as being formed of a single unit, the structure may be constructed from two or more curved longitudinal strips 1126 that are welded or attached together at the points shown. As with several of the other embodiments described in this section or elsewhere in this specification, one or more indentations can be made in the wall to assist in the transfer of fluid across the structure 1100 and through the structure 1100.

Fig. 14 illustrates a stabilization structure 1100, the stabilization structure 1100 being similar to the stabilization structure illustrated in fig. 13. Here, however, the zigzag longitudinal strips 1128 are joined to form diamond-shaped (rather than circular or oval) compartments 1129. It will of course be appreciated that this embodiment may also be manufactured using substantially straight strips of similar form to the embodiment illustrated in figures 8A-D.

Fig. 15 illustrates a stabilization structure 1100, the stabilization structure 1100 including vertical sections 1130 that are joined together at approximately perpendicular angles to form a quadrilateral or square compartment 1131. Preferably, the vertical section 1130 has a square or rectangular shape and has tapered portions 1132 that join the sections together in a movable and flexible configuration. As with other embodiments described in this section or elsewhere in this specification, this stabilizing structure 1100 may be manufactured as a single unit and preferably configured to collapse in a horizontal plane or direction, while remaining substantially non-collapsing in a vertical direction.

Fig. 16A-B illustrate another stabilization structure 1100, which is similar to the embodiment illustrated in fig. 15 above. The vertical sections 1130 are preferably joined together to form one or more quadrilateral or square compartments 1131. Here, however, the vertical section 1130 does not include the tapered portion 1132. However, there may be one or more indentations on the bottom side (wound-facing side) of the structure 1100, which function as described in the previous embodiments. While this embodiment may be manufactured from multiple vertical sections 1130, this embodiment is preferably molded as a single unit.

Fig. 16B illustrates a CT image of an embodiment of the stabilization structure 1100 described above with respect to fig. 16A, and the stabilization structure 1100 has been inserted into an abdominal wound. The subcutaneous fat layer 1190 is bilateral and is present on the muscle tissue layer 1192. After application of negative pressure (as illustrated), improved fascia re-approximation and wound closure can be observed. Here, the width of the wound along the illustrated view is reduced from approximately 82 mm to 52 mm, a reduction of 37%.

In some embodiments, the stabilizing structure described in this section or elsewhere in this specification (such as the stabilizing structure illustrated in fig. 11A-16B) may be molded entirely from a single type of material (such as plastic). In other embodiments, the stabilizing structure described in this section or elsewhere in this specification may be constructed via an overmolding process, where the more rigid portion of the structure is molded first, followed by molding of the hinge or flexible portion. In other embodiments of the stabilization structure described in this section or elsewhere in this specification, a soft polymer may be molded over the entire structure to soften the tactile feel of the device to protect surrounding organs and/or other tissue. In other embodiments, the soft polymer may be molded only on the bottom portion of the stabilization device, while in some embodiments, the softer polymer may be molded on the top and/or sides of the device. In some embodiments, the soft polymer may be molded over a particular edge of the stabilization structure (such as an edge on the bottom, sides, and/or top). In certain embodiments, the soft polymer may be molded on any side or combination of sides of the stabilization device. The soft polymer may act like a softening rim surrounding the hard edge of the stabilizing structure.

Fig. 32 illustrates an embodiment of a stabilization structure 3800 similar to the structure illustrated in fig. 11-16A. In this embodiment, the longitudinal strips 3802 and the intersecting strips 3804 are formed from a single sheet of material and form rows of flexible compartments 3806, the rows of flexible compartments 3806 configured to collapse in a horizontal plane. Because each of the longitudinal strips and the cross strips are formed of the same flexible material, application of a lateral force to the structure will cause the compartments to collapse generally independently of each other. In other words, one or more compartments in a row collapse, not necessarily the other compartments in the same row.

Example 5

In this next non-limiting experiment, the wound illustrated in the previous example, with the embodiment of the stabilizing structure device described above with respect to fig. 8A-E, was inserted into the abdominal cavity. In this experiment, and as illustrated in fig. 17A, a white foam insert was placed into the quadrilateral opening of the stabilizing structure, and the outer edge (in contact with the wound) was wrapped in black foam. The wound and stabilizing structure were then sealed with a drape and connected to a source of negative pressure as previously described.

Wound area measurements were taken before and after activation of the negative pressure source. Here, measureThe size of the wound before the application of negative pressure was 171 mm ² . After application of negative pressure, the area of the wound was greatly reduced to 55 mm as illustrated in FIG. 17B ² The reduction is 68%. Note that here also in the following example, as the wound area shrinks along its width, the length of the wound increases slightly, indicating that the tissue edges are returning to their original anatomical position.

Example 6

Fig. 18A-B illustrate the results of one non-limiting experiment similar to the non-limiting experiment illustrated above, wherein a stabilization structure similar to the embodiment of fig. 8A-E was inserted into the abdominal cavity. Here, the space in the quadrilateral opening of the stabilizing structure is empty and a layer of foam is wrapped around the outer edge of the structure.

Wound area measurements before and after application of negative pressure showed a 63% reduction in wound area from 155 mm ² Reduced to 58 mm ² 。

Without wishing to be bound by theory, the wound area was reduced to a greater extent in the previous example than the black foam control of example 1, which is believed to be because the wound device used therein does not compress significantly in the vertical direction when negative pressure is applied. This is different from conventional foam dressings, in which the application of negative pressure creates a downward pressure on the foam, as the air pressure presses onto the drape, [ thus causing the foam to collapse towards the wound bed, giving the drape a concave shape. The atmosphere acts primarily in a direction perpendicular to the surface of the drape. Thus, on the perimeter of the concave shape, closest to the wound edge or at the location where the drape approaches an angle perpendicular to the plane of the wound, the atmosphere now generates a force in a direction that pushes the wound open. Similarly, pressure changes along the foam dressing to a horizontal force that pushes the wound edge outward. With the stabilizing structure used in the various examples illustrated herein, the foam and other dressing components are not pushed outward and thus the wound edges may be made more accessible for faster wound closure. Indeed, in some experiments, certain embodiments of the wound device protrude upwardly onto the wound edge, and these vertical surfaces may thus allow atmospheric pressure to generate contractible forces acting on the device and/or wound edge.

Conventional negative pressure wound treatment typically uses foam (or other porous material) placed into the wound under a drape to which negative pressure is applied. In such a case, the application of negative pressure may create downward pressure on the foam as the air pressure presses on the drape, which then translates into a horizontal force along the foam dressing, which pushes the wound edge outward. Without wishing to be bound by theory, it is believed that some embodiments of the stabilizing structures, wound closure devices, and wound treatment devices, methods, and systems described below enable a greater reduction in wound area than traditional negative pressure treatment. It is believed that one of these factors is because the embodiments of the stabilizing structure and wound closure device described in this section or elsewhere in this specification do not compress significantly in the vertical direction when negative pressure is applied. With certain embodiments described in this section or elsewhere in this specification, foam and other dressing components are not pushed outward due to the negative pressure and, therefore, the wound edges can be made more accessible for faster wound closure and better wound healing.

21A-27B stabilizing structure and wound closure device

Fig. 21A is a photograph of an embodiment of a wound closure device including a stabilizing structure 2100 that may be placed or inserted into a wound. Here, the apparatus includes a plurality of compartments 2102, the compartments 2102 being provided side by side in a generally planar configuration. Preferably, the stabilizing structure 2100 is configured to collapse in a direction along a plane 2101 defined by the width of the device without significantly collapsing in a direction perpendicular to the plane 2101. That is, the stabilizing structure 2100 will collapse in the horizontal direction when viewed in the figures, but will not compress in the vertical direction. In some embodiments, the stabilizing structure collapses in coordination with the movement of the tissue. Here, the compartment 2102 is preferably open at both ends in a direction perpendicular to the plane 2101.

Each of the compartments 2102 is preferably formed with four walls 2104, each wall 2104 joined to the next by flexible joints 2106. The joints 2106 are preferably designed to be more flexible than the wall 2104 and facilitate collapse of the stabilizing structure 2100 in the direction of the plane. Of course, it will be understood that other configurations are possible, and in some embodiments, each compartment 2102 may be defined by fewer or more than four walls 2104, for example, five or six walls, thus forming a pentagonal or hexagonal compartment. The compartments 2102 may not necessarily be symmetrical, and in addition to the square-walled embodiments illustrated in this section or elsewhere in this specification, the compartments 2102 may form rectangles, diamonds, rhomboids, trapezoids, parallelipeds, rectangles, ovals, diamonds, and other such shapes.

One or more of the walls 2104 defining the one or more compartments 2102 can also include an insert 2115 disposed therein, and described in more detail below in fig. 22A-F. Preferably, the insert 2115 will be constructed of a material that is more rigid than the material used to construct the remainder of the wall 2104. Some suitable materials may include metals such as titanium, stainless steel, and primarily inert alloys (such as monel and hastelloy), and/or polymers such as polyurethane, silicone, rubber, isoprene, polyethylene, polypropylene, nylon, polyacrylate, polycarbonate, and PEEK. Some embodiments may also include composite materials, including resin-reinforced fiber composites, where the resin may be, for example, various types of epoxy resins. Suitable fibers may include glass, carbon nanotubes, graphene, and aramid (e.g., kevlar synthetic fibers). Preferably, the material chosen for the insert 2115 is not only sufficiently rigid, but also capable of adhering to the material used in the wall 2104. For example, the insert material is preferably capable of adhering to the softer polymer used in the wall 2104, such as silicone or polyurethane. The more rigid material used in the insert 2115 may provide additional resistance to collapse in a direction perpendicular to the plane of the stabilization structure 2100.

In some embodiments, one or more indentations 2109 may be provided between the walls 2104, which indentations 2109 may further help permit movement of the flexible joints 2106. Without wishing to be bound by theory, the indentations 2109 may also help distribute negative pressure and transport fluids throughout the stabilizing structure 2100 when negative pressure is applied, for example, in a clinical care environment. Some embodiments may also include pores in the walls 2104 or the junctions 2106, or be constructed of a porous material.

Preferably, a cavity 2108 is provided within each wall 2104 for an insert 2110 to be disposed therein. The wall 2104 may be molded around each insert 2115. The insert 2115 may also be inserted into the cavity 2108 after the wall 2104 is fabricated. Although the embodiments illustrated herein and in the images that follow show a single insert 2115 in each wall 2104, some embodiments may have one or more inserts 2115 disposed therein.

Fig. 21B illustrates an embodiment of a stabilization structure 2100, the stabilization structure 2100 having a number of features similar to those of fig. 21A. Here, insert 2111 includes structural differences compared to insert 2110, and insert 2111 is discussed in more detail below with respect to fig. 22E. When inserted or placed within the cavity 2108, one or more of the walls 2104 may include a hole 2105, the hole 2105 communicating through at least one aperture in the insert 2111. In addition to any indentations 2109, the one or more apertures 2105 may permit additional displacement of wound exudate and distribution of negative pressure within the stabilizing structure 2100.

Fig. 21C illustrates an embodiment of a stabilization structure 2100, the stabilization structure 2100 having similar features to other embodiments described previously. In this embodiment, the stabilization structure 2100 includes an insert 2112, the insert 2112 being described in more detail below in fig. 22F.

Similarly, fig. 21D illustrates an embodiment of a stabilization structure 2100 that includes an insert 2113, the insert 2113 being described in more detail below in fig. 22D. Fig. 21E illustrates an embodiment of a stabilization structure 2100 including an insert 2114, the insert 2114 being illustrated in more detail with respect to fig. 22A.

In the foregoing embodiments of the stabilization structure 2100 including the

various inserts

2110, 2111, 2112, 2113, 2114, and 2115, it will of course be appreciated that embodiments of the stabilization structure 2100 need not include only one type of insert. Likewise, each compartment 2102 or wall 2104 may include one or more different types of inserts, or no inserts at all. Thus, varying the different inserts and other properties of the compartment 2102 and the wall 2104 may permit the stabilizing structure 2100 to be adjusted according to the appropriate wound type for optimal wound closure and/or treatment.

Fig. 22A-F illustrate examples of different inserts that may be used as part of a stabilization structure 2100. Preferably, these inserts can be placed, molded into the wall 2104 (e.g., of the type illustrated above in fig. 21A-E) in the stabilizing structure 2100, or formed as part of the wall 2104. As explained below, various modifications may be made that may improve or alter the characteristics of the insert.

Turning now to fig. 22A, the embodiments of the insert 2114 illustrated herein are generally rectangular in shape and are adapted to be inserted or formed into one or more of the walls 2104 of an embodiment of the stabilizing structure 2100. In some embodiments, the height of one or more of the inserts 2114 can be greater than the width, and the height of the wall 2104 can be at least about 1 mm, at least about 5 mm, at least about 10 mm, at least about 15 mm, at least about 20 mm, at least about 25 mm, at least about 30 mm, at least about 35 mm, at least about 40 mm, at least about 50 mm, at least about 75 mm, at least about 100 mm, at least about 150 mm, at least about 200 mm, at least about 250 mm, at least about 300 mm, at least about 350 mm, at least about 400 mm, or greater than 400 mm, particularly in very obese patients. Preferably, in a typical patient, the height may range from about 10 mm to 40 mm. These measurements may be applicable to any of the stabilization constructs described in this section or elsewhere in this specification.

In some embodiments of any stabilizing structure described in this section or elsewhere in this specification, the width may be between about 1 mm to 30 mm, 2 mm to 25 mm, 4 mm to 20 mm, 6 mm to 18 mm, 8 mm to 16 mm, or 10 mm to 14 mm, preferably about 10.8 mm. These measurements may be applicable to any of the stabilization constructs described in this section or elsewhere in this specification.

The insert 2114 is preferably thin, but has sufficient structural strength to resist collapse, and in some embodiments of any stabilizing structure described in this section or elsewhere in this specification, may be at least about 0.01 mm to 10 mm, 0.2 mm to 8 mm, 0.4 mm to 6 mm, 0.5 mm to 4 mm, 0.75 mm to 3 mm, or 1-2 mm in thickness. These measurements may be applicable to any of the stabilization constructs described in this section or elsewhere in this specification.

In some embodiments of any of the stabilizing structures described in this section or elsewhere in this specification, a plurality of discrete stabilizing structures may be stacked on top of one another to form a wound closure device so as to extend the height of the device to any of the dimensions described in this section or elsewhere in this specification (including the dimensions provided for the insert above). Stacking multiple stabilization constructs may allow the clinician greater flexibility in their treatment strategy.

FIG. 22B illustrates an embodiment of the insert 2110 with the insert 2110 having a generally rectangular configuration but with two indents 2201, the two indents 2201 being cut diagonally across the top end of the insert 2100. The indents 2201 may facilitate removal of the insert 2100 from any indents 2109 that may be provided in the wall 2104. Moreover, the indents 2201 may also aid in inserting the insert 2100 into the cavity 2108 of the wall 2104. The dimple 2201 may also help to further define a channel or other opening in cooperation with the dimple 2109 for transporting or transferring fluid between each compartment 2102 and through each compartment 2102. The dimple 2201 may also help ensure that the entire stabilization structure can collapse more easily.

Fig. 22C illustrates an embodiment of an insert 2115, the insert 2115 being provided with two indents 2201 and one horizontal lip 2203. The horizontal lip 2203 may assist in inserting the insert 2115 into the cavity 2108 of the wall 2104, or may assist in securing the wall 2104 around the insert 2115 when molding the wall around the insert 2115. The horizontal lip 2203 may be beneficial to effectively reduce the volume of the insert at one end of the wall 2104, and may thus increase comfort in cooperation with the softer material used in the wall 2104, since the amount of wall material becomes correspondingly larger. In some embodiments, there may be a horizontal lip 2203 and/or an indent 2201 on both ends of the insert 2115 or other inserts illustrated elsewhere in this section or this specification. In some embodiments, the horizontal lip 2203 is approximately half the thickness of the overall insert 2115. For example, the insert 2115 may be between 0.5 mm and 4 mm thick, preferably 2 mm thick. If the thickness of the insert 2115 is 2 mm in size, the thickness of the horizontal lip 2203 may be 1 mm.

Fig. 22D illustrates an embodiment of an insert 2113, the insert 2113 being similar to the embodiment used in the stabilization structure 2100 illustrated in fig. 21D. This insert 2113 can include one or more apertures 2205, and in some embodiments, the apertures 2205 can be in communication with one or more apertures 2105, which apertures 2105 can be formed through one or more walls 2104. In some embodiments, the apertures 2205 are arranged in a 2x3 pattern as illustrated herein, but other arrangements are possible. There may also be an indentation 2201.

Fig. 22E illustrates an embodiment of an insert 2111, the insert 2111 being similar to the embodiment used in the stabilization structure 2100 illustrated in fig. 21B. The insert 2111 preferably includes two indentations 2201. A horizontal lip 2203 may also be provided. Preferably, one or more apertures 2205 may be formed therein. In some embodiments, one or more of the apertures 2205 may extend to an edge of the insert 2111, as illustrated. In some embodiments, the aperture 2205 may be configured with four apertures arranged around one central aperture, although other configurations are certainly possible. In some embodiments, a reduction in the amount of insert material at the location of the aperture may be advantageous to provide more softer wall material at the hinge point, where flexibility may thus be increased. In a preferred embodiment, the insert 2111 is 25 mm in height, 10.8 mm in width, and 2 mm in thickness. The center of the first set of apertures may be approximately 5 mm from the bottom edge of the insert 2111, so the center of the central aperture may be approximately 11 mm from the bottom, and the center of the top set of apertures may be 17 mm from the bottom.

Fig. 22F illustrates an embodiment of an insert 2112 that has some similarities to the embodiment used in the stabilization structure 2100 illustrated in fig. 21C above. Insert 2112 preferably may include one or more channels 2207 formed therein. Preferably, the one or more channels 2207 are disposed in a horizontal configuration across the width of the insert 2112. Although insert 2112 is preferably configured to remain substantially uncompressed in the vertical direction, as in several other embodiments described elsewhere in this section or this specification, the inclusion of one or more horizontal channels 2207 may help provide additional rigidity in the direction of the plane defined by compartment 2102. In such a case, the rigidity of the one or more walls 2104 may be enhanced, and thus the compression of the stabilization structure 2100 may be controlled such that substantially only at the one or more joints 2106 any collapse or bending occurs.

Fig. 23A-F illustrate an embodiment of a stabilization structure 3001, the stabilization structure 3001 configured to be inserted into a wound. The stabilizing structure 3001 preferably comprises at least one top strip 3002 extending in a first direction (e.g., along the x-axis) and at least one bottom strip 3004 extending in a second direction (e.g., along the y-axis perpendicular to the x-axis), the top and bottom strips preferably being arranged in an array comprising a plurality of

strips

3002, 3004. The

strips

3002, 3004 are preferably connected together in a movably interlocking arrangement, which preferably includes an interlocking mechanism 3006. The

strips

3002, 3004 are preferably arranged in a non-collapsed configuration, wherein the

strips

3002 and 3004 are disposed at approximately mutually perpendicular angles. This arrangement forms a first plane that the stabilization structure 3001 preferably adopts. Preferably, the stabilizing structure 3001 is stiffer in a direction perpendicular to the plane (i.e., in a vertical direction or along the z-axis), and thus substantially resists compression or deformation in that direction.

To assist in wound closure, the stabilizing structure 3001 is preferably movable from a substantially non-collapsed configuration to a collapsed configuration, which is illustrated in fig. 23F. As mentioned above, this may be beneficial for wound closure and healing. In use, the negative pressure can exert a closing force across the edges of the wound into which the stabilization structure 3001 is inserted. Because the structure 3001 is preferably configured to be substantially rigid in a vertical direction (i.e., perpendicular to the plane defined by the structure 3001), the pressure generated by atmospheric pressure applied to the structure 3001 via the drape is substantially concentrated downward, rather than outward, such that the wound edges are no longer pushed outward as in conventional negative pressure dressings.

Preferably, the area of the structure 3001 in the first plane is smaller because the structure 3001 has moved to the compressed configuration. Thus, the structure 3001 aids in wound closure because the structure 3001 aids in re-approximating the wound edges. In some embodiments, the stabilizing structure described in this section or elsewhere in this specification is capable of reducing its absorbent volume (i.e., the change in volume between the uncompressed stabilizing structure and the compressed stabilizing structure) by at least 10%, preferably at least 15%, and even more preferably at least 25% when in the collapsed configuration.

Fig. 23C-E illustrate close-up views of the interlock mechanism 3006. It should be noted that while it may be mentioned that there are various portions of the interlock mechanism 3006 on the top strip 3002 or the bottom strip 3004, such illustration should not be considered as limiting in orientation, and the same interlock mechanism 3006 may be configured with the top strip 3002 inverted from the bottom strip 3004.

In a preferred embodiment, the interlock mechanism 3006 preferably includes two snaps 3010, the two snaps 3010 extending downward from the top strip 3002. Preferably, these snaps 3010 are parallel to each other, and thus on opposite sides of the tab 3012 extending upward from the bottom strip 3004. Clasp 3010 preferably includes a lip or hook 3011, which lip or hook 3011 may itself be secured under an end 3013 at the distal end of protrusion 3012. In a preferred configuration, enlarged end 3013 is arranged such that all or a portion of lip 3011 engages enlarged end 3013. The lip 3011, in combination with the enlarged end 3012, can help prevent the top strip 3002 from disengaging from the bottom strip 3004 in a vertical direction. In some embodiments, the tab 3012 may abut against a bottom edge of the top strip 3002. However, in some embodiments, and as illustrated herein, there may be stabilizing posts 3014 for positioning tabs 3012 and the distal side of enlarged end 3013.

Fig. 24A-D illustrate an embodiment of a stabilization structure 3201, the stabilization structure 3201 being assembled in a manner similar to the embodiment illustrated above in fig. 23A-F. Here, interlock mechanism 3006 includes four snaps 3010, which snaps 3010 surround protrusion 3012 and enlarged end 3013 of protrusion 3012. Preferably, the snaps 3010 are arranged in a mutually orthogonal configuration, although different orientations are also contemplated. It should be understood that any number of snaps 3010 may be used to secure the tab 3012, such as three or five snaps 3010.

It should be noted that the embodiment illustrated herein will have a slightly larger compression configuration, as illustrated in fig. 24D, due to the addition of the additional clasp 3010 as compared to the embodiment illustrated in fig. 23A-F. This may be useful in some situations; for example, some wounds may require the wound edges to close more gradually, and the embodiments described herein may be well suited for this purpose. For example, in clinical situations involving compartment syndrome, particularly in the abdomen, it may be inappropriate, or undesirable, to apply complete wound closure, as wound closure may lead to complications such as excessive pressure on organs and underlying tissue structures, and/or reduced flow of blood to distal anatomy. In addition, in some cases, the wound closure is too rapid or complete, potentially causing excessive pain to the patient. Thus, in such types of wounds, it may therefore be beneficial to limit the amount of closure. In the case of compartment syndrome in the lower extremities, it may also be beneficial to limit the amount of closure.

Fig. 25A-E illustrate an embodiment of a stabilizing structure 3301, the stabilizing structure 3301 including an interlocking mechanism 3006 arranged in a tubular configuration. In this embodiment, the cup-shaped member 3020 is preferably configured to receive the enlarged end 3013 of the tab 3012. The tab 3012 may extend vertically from the top strip 3002. The cup-shaped member 3020 is preferably cylindrical or tubular in shape and may extend vertically from the bottom strip 3004, but it will be appreciated that the cup-shaped member 3020 and the protrusions 3012 may be on opposite strips.

Preferably, one or more slits 3021 are formed into the cup-shaped member 3020 to permit some "deformation" (give) to permit the projections 3012 to be received into the cup-shaped member. A lip or hook 3022 may also help secure the enlarged end 3013 of the tab 3012. There may also be stabilizing struts 3014 to prevent the protrusion 3012 from extending too far into the cup-shaped member 3020.

Fig. 25E illustrates a compressed view of an embodiment of a stabilization structure 3301. The compression configuration of this embodiment is slightly larger compared to fig. 23F.

Fig. 26 schematically illustrates an embodiment of a stabilizing structure 3400, the stabilizing structure 3400 configured to be inserted into a wound. Here, the stabilization structure 3400 is shown inserted into a wound 3405. Preferably, the stabilizing structure 3400 preferably comprises at least one, and more preferably at least two, elongate strips 3402, the longitudinal lengths of which may be oriented along the longitudinal axis of the wound 3405 or along the direction in which closure is attempted. Each of the one or more strips 3402 is preferably substantially rigid and extends substantially along the entire length of the wound 3405. In a preferred embodiment, strip 3402 is continuous and free of any breaks or hinges along its length. This is in contrast to certain other embodiments described above.

One or more braces 3404 are preferably attached to the stringer tape 3402 at one or more points. Preferably, the struts 3404 are movably attached, for example via a hinge-type attachment or flexible joint, such that the struts 3404 may collapse in a direction perpendicular to a longitudinal length defined by the length of the one or more long straps 3402. In some embodiments, the struts 3404 may form a non-perpendicular angle with respect to the long strips 3402 to more easily collapse. In embodiments comprising two or more straps 3402, the struts 3404 may be hinged between two parallel strips 3402.

It should be appreciated that while the struts 3404 may be configured to collapse in a direction perpendicular to the longitudinal length of the one or more strips 3402, the struts 3404 are preferably rigid in the vertical direction (i.e., in a direction extending upward from the plane defined by the wound 3405). In this manner, struts 3404 in combination with strips 3402 may form a stabilizing structure 3400, the stabilizing structure 3400 being substantially rigid in the vertical direction and collapsible in the horizontal direction (i.e., in the plane of wound 3405) perpendicular to the longitudinal axis of strips 3402.

Fig. 27A illustrates a top view of an embodiment of a stabilization structure 3400, the stabilization structure 3400 being cut into an oval and inserted into a wound 3405. Preferably, the stabilizing structure 3400 includes a plurality of elongate strips 3402, the longitudinal lengths of the elongate strips 3402 may be oriented along the longitudinal axis of the wound 3405 or along a direction in which closure is attempted. Each of the plurality of elongate strips 3402 is preferably substantially rigid and extends substantially along the entire length of the wound 3405. A plurality of intervening members are located between adjacent elongate strips 3402. These intervening members may be struts 3404 as described with respect to fig. 26, preferably attached to the elongate strip 3402 at one or more points. These intervening members may also be portions of the elongate strips, such as those described above with respect to fig. 23A-25E, that extend perpendicular to the elongate strip 3402 or at an angle to the elongate strip 3402. The stabilization construct of fig. 27A may also include the embodiments described with respect to fig. 21A-22F.

Fig. 27B illustrates a top view of an embodiment of an elliptical stabilizing structure 3400 inserted into a wound 3405. The configuration of this embodiment may be the same as that described above with respect to fig. 27A. Additionally, foam 3406 may also be inserted between and around the stabilizing structures.

28A-31 and 33-35

Fig. 28A illustrates an embodiment of a method of closing a wound by applying tension along the axis of the wound 3405 using any of the stabilizing structures described in this section or elsewhere in this specification, supra or infra. In this example, tension is applied along the longitudinal axis of the wound when the wound is viewed from above, generally indicated by arrow 3407. Tension along the longitudinal axis may prevent the wound from contracting along the longitudinal axis, however, tension along the longitudinal axis may cause the lateral edges of the wound to be drawn together, thereby promoting wound closure. In some embodiments, additional inward tension may be applied to the lateral edges of the wound, thereby providing additional wound closure force.

Fig. 28B illustrates an embodiment of a method of closing a wound by using a stabilizing structure 3400, the stabilizing structure 3400 collapsing and lengthening when treating the wound under negative pressure. As illustrated, the stabilizing structure 3400 may be cut to an appropriate size to approximate the shape of a wound (e.g., an oval), and placed in the wound 3405. In some embodiments as described above, the stabilizing structure may be provided with a plurality of diamond-shaped compartments, and the compartments are arranged in the wound in an orientation that flattens the compartments as the lateral edges of the wound come closer together, while becoming longer along the longitudinal axis of the wound. It will be appreciated that while this structure is configured to collapse horizontally within the wound under negative pressure in a direction perpendicular to the longitudinal axis of the wound, the structure is substantially rigid in the vertical direction. Line 3408 represents the length of the structure before it is lengthened under negative pressure, while line 3410 represents the final length of the structure after it is collapsed and lengthened under negative pressure.

Lines

3412 and 3414 represent the length of a particular region within the stable structure. In some embodiments, when the wound is treated by applying negative pressure, the structure will collapse inwardly in one axis, causing the structure to lengthen in the other axis by some additional amount, which may be the sum of the lengths of

lines

3412 and 3414. In some embodiments, the amount by which the structure is lengthened may be a value other than the sum of

lines

3410 and 3412.

In some embodiments, this collapse may occur slowly, applying an increasing longitudinal tension over a long period of time. In some embodiments, the structure may collapse and lengthen immediately upon application of negative pressure. In further embodiments, the collapsing may occur at any rate.

Fig. 29A-C illustrate another embodiment of a stabilization structure 3500. The stabilizing structure 3500 comprises a plurality of parallel arranged elongate strips 3502, the longitudinal length of which elongate strips 3502 may be aligned with the longitudinal axis of the wound when placed in the wound. The stabilizing structure also includes a plurality of intervening members 3504, the intervening members 3504 being connected to the elongate strips 3502 by joints 3506. As illustrated, the plurality of intervening members 3504 between adjacent elongate strips 3502 define a row of compartments 3508 between each pair of adjacent elongate strips.

In some embodiments, the elongate strips 3502 are rigid. In certain embodiments, the elongate strips 3502 are semi-rigid. In certain embodiments, the elongate strips 3502 are flexible. In some embodiments, the elongate strips 3502 are compressible. As illustrated in fig. 29A-29C, one embodiment includes a plurality of strips that are rigid in the vertical dimension, but may also be flexible along their length and capable of bending.

In some embodiments, the intervening members 3504 are rigid. In certain embodiments, intervening member 3504 is semi-rigid. In certain embodiments, the intervening members are flexible. In some embodiments, the intervening members 3504 are compressible. As illustrated in fig. 29A-29C, one embodiment includes intervening members in the form of panels equally spaced between adjacent strips for defining a plurality of similarly shaped (e.g., diamond shaped) compartments. In other embodiments, the intervening members need not be equally spaced. The intervening members may be attached to the straps by joints 3506 in the form of hinges (e.g., living hinges between the straps and intervening members or a more flexible piece of material).

In some embodiments, the plurality of intervening members 3504 are configured to pivot relative to the elongate strips 3502 and collapse so as to allow the elongate strips to collapse relative to one another and come closer together. In some embodiments, the joints 3506 are configured to pivot and collapse in only one direction. In certain embodiments, the joint 3506 is configured to pivot and collapse in two directions, including a full 180 degree rotation relative to the elongate strip 3502. In some embodiments, as the joints pivot, the joints pivot fully to seat the intervening member 3504 against the elongate strap 3502. In some embodiments, these joints do not pivot completely, and the intervening member does not abut the elongate strips 3502.

Preferably, in certain embodiments, by controlling the direction of occurrence of the pivoting, the length of collapse of the stabilizing structure 3500 may be controlled. In certain embodiments, because the elongate strips are rigid, the compartments 3508 in a row between adjacent elongate strips are configured to collapse together when the adjacent elongate strips 3502 are collapsed relative to each other. In some embodiments, one or more rows of compartments 3508 between adjacent straps 3502 are configured to collapse in a first direction and one or more rows of compartments between adjacent straps 3502 are configured to collapse in a second direction opposite the first direction. 29A-29C, the orientation of the compartments in adjacent rows alternates such that the compartments in a first row collapse in a first direction, while the compartments in the next row collapse in a second, opposite direction. The joints 3506 can be configured such that the joints 3506 in adjacent rows collapse in different directions.

The length of the collapsed structure can be modified by configuring the junction 3506 and/or compartment of the stabilizing structure to collapse in a preferred direction. The collapsed length of the embodiment shown in fig. 29A-29C will be shorter than a structure in which all rows of compartments 3508 are configured to collapse in the same direction. Thus, the collapsed length of the structure may be controlled depending on the orientation of the compartments and the direction in which the intervening member collapses between adjacent rows. In some embodiments described above with respect to fig. 28A-28B, the stabilizing structure preferably lengthens after collapsing under negative pressure. In other embodiments, it may be preferred that the stabilizing structure does not lengthen after collapsing under negative pressure.

In fig. 29A-29C, intervening members 3504 in adjacent rows are generally aligned such that the intervening members connect to the elongate strips at approximately the same location on opposite sides of the elongate strips and share the same joint 3506 location. In other embodiments, the intervening member 3504 between the first and second

elongate strips

3502, 3502 is offset relative to the intervening member 3504 between the second and third

adjacent strips

3502, 3502. In these embodiments, intervening members 3504 are staggered such that intervening members 3504 do not share the same joint 3506 position.

As shown in fig. 29A-29C, the enclosed compartment 3508 formed by the two intervening members and the two sections of the elongate strip is quadrilateral. In some preferred embodiments, the closed shape may be square, rectangular, diamond-shaped, rectangular, oval, and/or parallelepiped. In some embodiments, the closed shape is a rhomboid. In some embodiments, the closed shape is a trapezoid.

In certain preferred embodiments, the joints 3506 may be configured to limit the range of motion of the intervening member 3504, and may serve to prevent the intervening member 3504 from being completely perpendicular to the adjacent straps. Thus, the joint may be configured to preset intervening member 3504 to a partially collapsed position. For example, a lip or other portion of material at the junction may be used to limit the angular movement of the intervening member. The lip or other portion of material may also prevent the joint from completely collapsing and flattening. In some embodiments, the joint may be configured to prevent the intervening member from rotating 180 degrees along the plane formed by the strips.

In some embodiments, when the stabilization structure 3500 is placed in a wound, the elongate strips 3502 are positioned generally parallel to the lateral edges of the wound. Preferably, the stabilizing structure is configured in the wound such that the elongate strips are positioned parallel to the longitudinal axis of the wound, as described above with respect to fig. 28A-28B. These strips may also be curved along their length and arched upward to fit within the wound. The stabilizing structure may be cut to the appropriate size to fit the structure in the wound. In other embodiments, the elongate strips 3502 are positioned perpendicular to the edges of the wound, or may not be oriented along any edges of the wound.

In the embodiment of fig. 29A-29C, as well as other embodiments of the stabilization construct described in this section or elsewhere in this specification, the strips may be constructed from a material selected from the following group of materials: silicone, polyurethane rigid plastics, semi-rigid plastics, flexible plastic materials, composites, biocompatible materials, and foams. In some embodiments, the intervening members may be constructed from a material selected from the group consisting of: silicone, polyurethane, rigid plastic, semi-rigid plastic, flexible plastic material, composite material, biocompatible material, and foam. In some embodiments, the stabilizing structure is surrounded by an absorbent material. In certain embodiments, the stabilizing structure is surrounded by a non-absorbent material. In some embodiments, the material surrounding the stabilizing structure is foam. In some embodiments, the space between the intervening member 3504 and the elongate strip 3502 is filled with foam.

Fig. 30A-G illustrate an embodiment of a stabilization structure 3600, the stabilization structure 3600 being similar to the stabilization structure described above with respect to fig. 29A-C and 28B. As illustrated in fig. 30A, in some embodiments, the stabilizing structure 3600 includes a plurality of elongate strips 3602, the elongate strips 3602 connected by a plurality of intervening members 3604 at a plurality of joints 3606. As illustrated in fig. 30A-G, the plurality of intervening members includes a plurality of bars 3604 that connect adjacent elongate strips together and to the elongate strips at the upper and lower joint locations. In one embodiment, the plurality of joints includes a plurality of pins 3606, the pins 3606 being connected to the bar and received in upper and lower vertical openings in the strip 3602. Other types of contacts are also contemplated, including ball contacts. The bars are preferably equally spaced inside a row between adjacent elongate strips and may be offset or staggered in adjacent rows such that in adjacent rows the bars are connected to the elongate strips at a location between the bars of the first row. In other embodiments, the intervening member may comprise a wire or other elongate structure configured to extend between adjacent elongate strips.

Preferably, as illustrated in the top view of fig. 30B and the front view of fig. 30C, in certain embodiments, the pins cause the bars to protrude above the vertical top and bottom of the elongate strips 3602. In other embodiments, the bar 3604 may be connected to the elongated strip such that the bar 3604 is positioned flush with the vertical top and the vertical bottom of the elongated strip 3602. In still other embodiments, the bar 3604 may be connected such that it is located below the vertical top of the elongate strip 3602 and above the vertical bottom of the elongate strip.

As illustrated in fig. 30A and 30C, the joint 3606 may preferably include a plurality of stops 3608, the stops 3608 configured to limit rotation of the rod relative to the ribbon. The stops may project vertically from the straps to limit movement of the bar. For example, these stops may be used to prevent the bars from being perfectly vertical relative to adjacent strips, and may be used to collapse adjacent rows in a preferential direction. As shown in fig. 30A, a first row may be provided with bars angled in a first direction and a second row may be provided with bars angled in a second direction. In some embodiments, there are two stops per bar on a given strip for limiting movement in two directions. In other embodiments, there is one stop per bar or three or more stops on a given strip.

Fig. 30E-G illustrate a stabilization structure 3600 in a collapsed configuration. Similar to the structures of fig. 29A-C and 28B, the structure 3600 may be positioned in a wound in an orientation configured to collapse in a direction perpendicular to a longitudinal axis of the wound. As mentioned above, the stabilizing structure may be surrounded by or filled with an absorbent material such as foam. In one embodiment, because the vertical space between the upper and lower bars of the structure 3600 is open (best shown in fig. 30C), elongated blocks of foam or other compressible material may be placed between adjacent strips to provide the desired compressibility as the structure collapses.

Fig. 31 illustrates an embodiment of a stabilizing structure 3700, the stabilizing structure 3700 similar to the structures illustrated above with respect to fig. 28B, 29A-C, and 30A-G. In certain embodiments, the stabilizing structure 3700 may collapse in any of the ways described above. The illustrated elongate strip 3702 is formed in half and can be split along line 3708. The intervening member 3704 may take the form of a panel as described above. The joints 3706 on the upper half of the elongated strip may include pins on opposite sides of the strip, extending downward from the top of the upper half of the strip. The joints 3706 on the lower half of the elongated strip may include pins on opposite sides of the strip, extending upward from the bottom of the lower half of the strip. These pins may engage with vertical openings located at the four corners of the intervening member 3704. These pins may engage openings in the panel when the upper half and the lower half are brought together. The upper half and the lower half may be secured by a number of mechanisms, such as using an adhesive and mechanical attachment.

In the embodiment of fig. 31, the intervening member 3704 may be easily removed or replaced because the two halves of 3702 can be separated along line 3708. In some embodiments, only some of the intervening members 3704 are removed. In certain embodiments, alternating intervening members 3704 are removed. In certain preferred embodiments, the intervening members are removed in a preferential manner so as to allow the stabilizing structure 3700 to collapse in a controlled manner best suited for the particular wound. For example, junction 3706 may have a variable degree of rotational resistance, allowing for controlled collapse of the structure by adding or removing intervening member 3704. Additionally, some stops, such as the one described with respect to fig. 30A, may be incorporated into the structure or any other structure described in this section or elsewhere in this specification to further control collapse. In some embodiments, some intervening members are replaced or removed in order to maximize the collapsed length of the structure 3700. In certain embodiments, some intervening components are replaced or removed in order to minimize the collapsed length of the structure 3700. In some embodiments, some intervening members are replaced or removed to achieve a desired length of the collapsed structure.

Fig. 33 illustrates another embodiment of an elongate strip 3900 that may be used to form a stabilizing structure, the stabilizing structure 3900 being similar to the stabilizing structure illustrated in fig. 8A-D. The first strip 3902 illustrated in the upper portion of fig. 33 may be an elongate strip provided with a plurality of spaced apart openings 3904, the openings 3904 extending along a central axis of the strip. The second strip 3906 illustrated in the lower portion of fig. 33 can be provided with a plurality of spaced indentations 3908, the indentations 3908 extending from the upper and lower edges of the second strip and separated by an intermediate portion. First and second pluralities of

strips

3902 and 3906 can be assembled into a stabilizing structure similar to the stabilizing structure shown in fig. 8A, 8C, and 8D, wherein the first plurality of strips 3902 are arranged parallel to one another and the second plurality of strips 3906 are arranged parallel to one another. The first and

second strips

3902, 3906 engage each other through intermediate portions 3910 of the second strip (the intermediate portions 3910 are positioned through openings 3904 in the first strip) to place the first strips at an angle relative to the second strips. This structure is configured to collapse in the horizontal plane while remaining rigid in the vertical plane.

Fig. 34 illustrates an embodiment of a stabilization structure 4000, the stabilization structure 4000 being similar to the embodiment of fig. 13 described above. A plurality of longitudinal strips 4002 may be provided, each in the form of an undulating strip that, when joined face-to-face, form one or more circular or oval compartments 4004. The entire structure may collapse into a substantially flat configuration and may be housed in a roll 4006. To use the stabilization construct, a portion of the construct may be unfolded and cut to a desired length. Preferably, when the stabilizing structure is deployed, the stabilizing structure expands to its natural expanded configuration. It should be understood that other embodiments of stabilizing structures (other than the embodiment using the undulating strips of fig. 13) may be assembled in a roll-to-roll configuration.

FIG. 35 illustrates another embodiment of a stabilization construct. In this embodiment, the stabilizing structure 4100 has an elongated, preferably elliptical shape, wherein a plurality of the cells 4102 within the elliptical shape are arranged in a plurality of concentric rings 4104. In the illustrated embodiment, the central oval compartment is surrounded by two oval rings. Other embodiments may contain more than two elliptical rings.

36A-44 stabilizing structure and wound closure device

Fig. 36A-F illustrate an embodiment of a stabilization structure 4200, the stabilization structure 4200 being similar to the embodiment described above with respect to fig. 29A-32. The stabilizing structure may include a plurality of parallel arranged elongate strips 4202, the longitudinal length of the elongate strips 4202 may be aligned with the longitudinal axis when placed in a wound. The stabilization structure may also include a plurality of intervening members 4204, the intervening members 4204 being connected to the elongate strips 4202 via joints 4206. In certain embodiments, the stabilization structure 4200 may be collapsed with or without the application of negative pressure, using any of the means described in this section or elsewhere in this specification. For example, the stabilizing structure may collapse significantly more in one plane than in another. In some embodiments, the stabilizing structure may be constructed of any of the materials described in this section or elsewhere in this specification, including: flexible plastics such as silicone, polyurethane, rigid plastics such as polyvinyl chloride, semi-rigid plastics, semi-flexible plastics, biocompatible materials, composites, metals, and foams.

The stabilizing structure 4200 and all stabilizing structures and wound closure devices described in this section or elsewhere in this specification may collapse in a dynamic manner on a variety of time scales. In certain embodiments, most of the collapse may occur within the first few minutes after the negative pressure is applied. However, after the initial collapse, the stabilizing structure or wound closure device may continue to collapse at a much slower rate, thereby applying an increasing longitudinal tension over a long period of time and drawing the edges of the wound closer together. By slowly pulling the wound edges closer together over time, the stabilizing structure or wound closure device allows the surrounding healing tissue to remodel in concert with the closure of the device or stabilizing structure. The slow dynamic closure of the wound may allow for increased healing rates of the surrounding tissue, as the collapsed structure or device slowly brings the edges of the wound closer together, and does not stress the newly formed or weakened tissue too quickly.

In some embodiments, the stabilizing structure described in this section or elsewhere in this specification can be placed into the wound for a period of time and then removed or replaced with another stabilizing structure. For example, the stabilizing structure may be inserted into the wound over a period of time, thereby promoting wound closure by drawing the edges closer together. After a period of time has elapsed, the stabilization structure may be replaced with a stabilization structure of a different size or collapsibility (e.g., a stabilization structure that is smaller in size or has a reduced density). This process may be repeated iteratively, thereby continuously drawing the wound edges together over time and allowing for continuous repair and remodeling of the surrounding tissue.

In some embodiments, the stabilizing structure is configured to remain in the wound for at least about less than 1 hour, at least about 2 hours, at least about 4 hours, at least about 6 hours, at least about 8 hours, at least about 12 hours, at least about 24 hours, at least about 2 days, at least about 4 days, at least about 6 days, at least about 1 week, at least about 2 weeks, at least about 3 weeks, or more than 3 weeks.

In certain embodiments, as much as 90% collapse of the stabilizing structure or wound closure device may occur within the first few minutes after application of negative pressure, while the remaining 10% collapse may occur slowly over many minutes, hours, days, weeks, or months. In other embodiments, collapse of up to about 80%, collapse of up to about 70%, collapse of up to about 60%, collapse of up to about 50%, collapse of up to about 40%, collapse of up to about 30%, collapse of up to about 20%, collapse of up to about 10%, or collapse of about 0% will occur immediately within the first few minutes after application of negative pressure, while the remainder of the collapse occurs at a much slower rate, such as over the course of many minutes, hours, days, weeks, or months. In other embodiments, the stabilizing structure may collapse with a variable speed.

In some embodiments, the entire collapse occurs at a slower rate, while in other embodiments, the entire collapse occurs almost immediately within the first few minutes. In further embodiments, the collapsing may occur at any rate, and the rate may vary over time. In certain embodiments, the rate of collapse may be altered in a variable manner by adding and/or removing portions of the structure, or by controlling the application of negative pressure and irrigation fluid.

As illustrated in the perspective view of fig. 36A and the top view of fig. 36B, the intersection of access member 4204 and elongate strip 4202 may define a plurality of compartments 4210. In certain embodiments, the compartment 4210 may have any of the shapes and sizes described in this section or elsewhere in this specification, such as the shapes and sizes described with respect to fig. 29A-29C. For example, the shape of the compartment may be square, diamond, rectangular, oval, and/or parallelepiped.

Joint 4206 is configured to allow intervening member 4204 to collapse, similar to the joints illustrated in fig. 29A-C and 31. Joints 4206 may be configured to allow an intervening member to be collapsed in any manner described with respect to other embodiments for use in this section or elsewhere in this specification, such as the manner described with respect to fig. 29A-C. For example, joints 4206 may be configured to allow or preferentially collapse a first row of intervening members 4204 in one direction and allow or preferentially collapse an adjacent row in another direction.

Elongate strip 4202 may include alternating flexure segments 4212 and support segments 4214. In a preferred embodiment, the flexure section 4212 may be constructed of a flexible or semi-flexible material such as silicone and/or polyurethane. However, any flexible or semi-flexible material may be suitable. The flexure section 4212 may flex in any direction, allowing the stabilization structure to collapse more easily in any direction, but especially in the horizontal plane. In a preferred embodiment, the support section 4214 may be constructed of a rigid or semi-rigid material such as polyvinyl chloride (PVC). However, any rigid or semi-rigid material may be suitable. In the illustrated embodiment, the elongate strip 4202 comprises an elongate strip of a first material, such as silicone and/or polyurethane, with a plurality of elongate inserts of a second, more rigid material 4214 embedded in the first material. Thus, the flexure segment 4212 is a region of the elongate strip 4202 where no more rigid inserts are provided.

As illustrated in fig. 36A-D, the support sections 4214 may be larger than the flexure sections 4212. In one embodiment, the support sections 4214 may be approximately three times larger than the flexure sections 4212 (such as by distracting the three compartments 4210). In other embodiments, the support segments 4214 may be the same size as the flexure segments 4212. In further embodiments, the flexure segments 4212 may be larger than the support segments 4214. Alternatively, the length and width of the various sections of the elongate strip 4202 may be variable. For example, the height of the support segments 4214 may be reduced such that the support segments 4214 do not extend from approximately the top to approximately the bottom of the stabilization structure 4200. In some embodiments, the smaller support section may encompass approximately half of the height of the elongate strip 4202. In certain embodiments, the support segment 4214 may be located in an upper or lower portion of the elongate strip. Such an embodiment may be achieved by using an insert of a second material having a height that is less than the height of the first material forming the elongate strips 4202.

In some embodiments, the support segments do not alternate with the flexure segments 4212, but rather, the elongate strips 4202 are constructed entirely of support segments 4214 (e.g., silicone strips or other material, embedded more rigid inserts extending throughout their length, or the more rigid material itself). Alternatively, the entire elongate strip 4202 may be constructed of only the flexure section 4212 (e.g., a strip made only of silicone or other more flexible material).

The elongated strips 4202 may be made of a female mold, which may further enclose the entire stabilizing structure 4200. The support section 4214 may be inserted into a female mold and then sprayed with a flexible polymer, such as silicone and/or polyurethane, to encase the support section 4214 within the flexible polymer frame. The support segments 4214 may be inserted into the mold in any desired manner or number, allowing for many possible variations in the stabilization device.

In further embodiments, the support segments 4214 may be inserted into the elongate strip 4202 and/or may be removed from the elongate strip 4202, and may be inserted and/or removed to modify the collapsibility of the stabilization structure 4200. After having been placed in a wound, support segments 4214 may be inserted into stabilization structure 4200 and/or removed from stabilization structure 4200 in order to variably control the collapse of stabilization structure 4200. In these embodiments, the elongate strips 4202 may form pockets that open from one side (e.g., from the top) to allow insertion and removal of the support segments 4214.

Fig. 36C-D illustrate an embodiment of a single support section 4214 in more detail. The support member 4214 may be a flat plate-like structure having a rectangular shape with a length greater than its height and two parallel surfaces. The support section may comprise at least one indentation 4220, preferably located on an upper edge of the support section. In other embodiments, the indentation or indentations may be located on the bottom or sides of the support section. In further embodiments, the top indentation may have a corresponding bottom indentation. In certain embodiments, the indentation may be configured to allow tearing of the support section in a transverse line across the support section. This indentation or indentations 4220 may advantageously provide flexibility to the structure. The indentations 4220 may allow the stabilization structure to flex more easily in a horizontal plane or in a vertical plane. The indentations 4220 may further allow the stabilization structure to twist in multiple planes. The indentations 4220 may also improve fluid flow within the stabilization structure 4200. In some embodiments, the support section does not contain an indentation, and the uppermost edge is flat. The indentation 4220 may be located at other locations on the support section, such as a bottom edge or side. The shape of the indentations may be rounded triangles as in fig. 36C-D, or any other similar shape.

In some embodiments, the intervening member 4204 may include a first material 4216 and have an insert 4218 made of a more rigid material. One embodiment of an insert is illustrated in fig. 36E-F. In certain embodiments, the insert 4218 is placed within a female mold and a flexible polymer, such as silicone and/or polyurethane, is injected around the insert to embed the insert 4218 within the flexible polymer frame. The inserts 4218 may be inserted into the mold in any desired manner or number, allowing for many possible variations in the stabilization device. In other embodiments, the first material 4216 may take the form of a sleeve configured to receive the insert 4218. Also, the sleeve 4216 may be configured to allow removal of the insert 4218, such as by providing an opening in the top of the sleeve. In a preferred embodiment, the first material 4216 is constructed from a flexible or semi-flexible material such as silicone and/or polyurethane. However, any flexible or semi-flexible material may be suitable. In a preferred embodiment, the insert 4218 is constructed of a rigid or semi-rigid material such as polyvinyl chloride. However, any rigid or semi-rigid material may be suitable.

Fig. 36E illustrates a front view of the insert 4218, while fig. 36F illustrates a side view of the insert 4218. In one embodiment, the insert may be a flat plate-like structure having a rectangular shape with a height greater than its width and two parallel surfaces. The insert may include a recess 4222. The recess is preferably located at the upper portion of the insert, however, the recess 4222 may be located on either side of the insert, or on the bottom. The notches 4222 may be configured such that they help to allow fluid to flow through the stabilization structure by providing a flow path. The notches 4222 may improve the flexibility of the stabilization structure 4200 and are configured to allow the stabilization structure 4200 to collapse more efficiently.

In some embodiments, the stabilization structure 4200 of fig. 36A-B can be configured to include perforations or removable sections that allow portions of the device to be separated from the rest of the device. For example, perforations may be incorporated into joints 4206 between various compartments housed within stabilization structure 4200, allowing individual rows or compartments to be removed in order to modify the shape of stabilization structure 4200. In some embodiments, as described above with respect to fig. 36C-D, these segments may be detached along perforations or lines in the elongate strip corresponding to the indentations 4220.

In some embodiments, insert 4218 may be embedded within first material 4216 in a variable number of intervening members 4204 to control the shape and collapse of stabilization structure 4200. In other embodiments, insert 4218 may be inserted directly into a sleeve comprised of first material 4216 within intervening member 4204 to control the shape and collapse of stabilization structure 4200.

For example, insert 4218 may be present in at least about 5% of the access members, at least about 10% of the access members, at least about 15% of the access members, at least about 20% of the access members, at least about 25% of the access members, at least about 30% of the access members, at least about 35% of the access members, at least about 40% of the access members, at least about 45% of the access members, at least about 50% of the access members, at least about 55% of the access members, at least about 60% of the access members, at least about 65% of the access members, at least about 70% of the access members, at least about 75% of the access members, at least about 80% of the access members, at least about 85% of the access members, at least about 90% of the access members, at least about 95% of the access members, or about 100% of the intervening members.

In certain embodiments, a variable number of support segments 4214 may be buried within the elongate strips 4202 to control the collapsibility of the stabilization structure 4200. In other embodiments, a variable number of support sections may be inserted into pockets housed within the elongate strips 4202 to control the collapsibility of the stabilization structure. For example, the support segment 4214 may be present in at least about 5% of the total length of the elongate strip, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100% of the total length of the elongate strip.

In certain embodiments, the insert 4218 or support segment 4214 may be inserted and/or removed over time to variably control the collapse of the stabilization structure 4200. For example, while all available sleeves 4216 of the initial stabilization structure may contain inserts, additional inserts 4218 may be removed over time after the initial placement of the stabilization structure in the wound, thus causing the stabilization structure 4200 to collapse even further. An insert may also be added to the stabilizing structure after it is inserted into the wound, thereby reducing the collapsibility of the stabilizing structure 4200. Thus, the addition and/or removal of insert 4216 or support segment 4214 allows for variable control over the collapse of stabilization structure 4200. In a similar manner, the support segments 4214 may be inserted into and removed from the elongate strip over time in order to provide variable control over the collapse of the stabilization structure 4200.

In certain embodiments of the stabilization structures illustrated in this section or elsewhere in this specification, such as in stabilization structure 4200 illustrated in fig. 36A, the flexibility of various sections of the stabilization structure is enhanced by thinning these sections. For example, in some embodiments, rather than using a flexible material for the flexure sections 4212 of the elongate strips 4202, the flexure sections 4212 may be constructed from a material similar to the material used to construct the support sections 4214. In this embodiment, since the support section 4212 is thicker than the flexure section 4212, the support section 4212 will not flex to the degree of flexure experienced by the flexure section 4212. In certain embodiments, the entire stabilization structure 4200 may be constructed from a single rigid or semi-rigid material, but by thinning certain areas of the stabilization structure 4200, the entire stabilization structure 4200 is made to have different rigid and flexible portions. In further embodiments, the joints 4206 may be thinned, allowing for greater flexibility as compared to surrounding sections. In some embodiments, thinning a section of the stabilization structure 4200 may allow the thinner portion to be more easily removed from the structure.

As described above with respect to fig. 11A-16B, and applicable to all of the stabilization structures or wound closure devices described in this section or elsewhere in this specification, a soft polymer may be molded over the entire stabilization structure 4200 in order to soften the tactile feel of the device to protect surrounding organs and/or other tissue. In other embodiments, the soft polymer may be molded only on the bottom portion of the stabilization device 4200, while in some embodiments, a softer polymer may be molded on the top and/or sides of the device. In some embodiments, a soft polymer may be molded over specific edges of the stabilization structure 4200, such as edges on the bottom, sides, and/or top. In certain embodiments, a soft polymer may be molded on any side or combination of sides of stabilization structure 4200. The soft polymer may act like a softening rim surrounding the hard edge of the stabilization structure 4200.

Fig. 37A-D illustrate various views of another embodiment of a stabilization structure 4200, the stabilization structure 4200 being similar to the stabilization structures depicted in fig. 29A-C and fig. 36A-E. As with the stabilization structure embodiment depicted in fig. 36A-F, stabilization structure 4200 includes an elongate strip 4202 and an intervening member 4204. Elongate strip 4202 may include openings 4224, openings 4224 configured to allow fluid to pass through elongate strip 4202. To construct these openings, holes or other shapes can be drilled directly through the elongate strips. In the embodiment illustrated and further shown in fig. 37C and 37D, elongate strip 4202 also includes a more rigid insert 4214 as described above. In these embodiments, an opening 4224 may be drilled through the rigid insert 4214 in the location of the strip where the insert is located, and an opening 4224 may be drilled through the flexure section 4212 without the insert. These openings may be configured to distribute fluid evenly throughout the stabilization device and/or to direct fluid flow along a particular path or direction. In other embodiments, the intervening member includes an opening similar to that described with respect to the elongate strip.

Fig. 38A-B illustrate an embodiment of the stabilizing structure 4400, the functional and structural elements of the stabilizing structure 4400 being similar to the embodiment of the stabilizing structure depicted in fig. 36A-F. Similar to the other stabilizing structures previously described, the stabilizing structure 4400 includes an elongate strip 4402 and an intervening member 4404. The elongate strip 4402 may be a single monolithic strip without distinct flexing or supporting segments. In some embodiments, the elongate strips 4402 may be constructed entirely of a rigid or semi-rigid material, such as polyvinyl chloride. In other embodiments, the elongate strip 4402 may be constructed entirely of a flexible or semi-flexible material such as silicone and/or polyurethane. Similar to the embodiment illustrated in fig. 36A-F, the stabilizing structure 4400 may collapse in any manner illustrated in this section or elsewhere in this specification, on any time scale illustrated in this section or elsewhere in this specification.

Fig. 38C depicts embodiments herein in which the elongate strip 4402 includes an opening 4416 to allow passage of fluid, similar to the passage of fluid illustrated in fig. 37A-D.

Fig. 39A-B illustrate an embodiment of a stabilization structure 4500, the stabilization structure 4500 being similar to that described above with respect to fig. 29A-32. Stabilizing structure 4500 includes an elongate strip 4502 and an intervening member 4504. The access member 4504 may also include a window 4506, the window 4506 configured to allow passage of fluid. In some embodiments, all of the intervention members 4504 may include windows 4506, however, in other embodiments, only the horizontally outermost intervention member 4504 includes windows 4506, while the internal intervention members are similar to other embodiments described in this section or elsewhere in this specification.

In certain embodiments, at least about 5% of the access members comprise a window, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100% of the access members.

Elongate strip 4502 may also include a gap 4508 configured to allow fluid to pass through. The gap may extend over almost the entire length of the elongate strip 4502, or only a portion of the length of the elongate strip 4502.

Fig. 39B illustrates an embodiment of a stabilization structure 4500 in which window 4506 also includes a bar 4510. In certain embodiments, at least about 5% of the windows comprise rods, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100% of the windows.

Fig. 40 is a photograph of an embodiment of a foam layer 4600, which foam layer 4600 may be used with any of the stabilization structures or wound closure devices described in this section or elsewhere in this specification. As described above, the foam layer 4600 may be located above or below the stabilizing structure or wound closure device. In some embodiments, the foam layer 4600 is located both above and below the stabilizing structure or wound closure device. The foam layer 4600 may surround the perimeter of the stabilization structure or wound closure device, or completely surround the entire stabilization structure or wound closure device. Foam layer 4600 may be constructed from an absorbent material, a material configured to distribute fluids, or both.

The foam layer 4600 also includes fingers 4602, and the fingers 4602 may extend from the foam layer into a stable structure or closure device. For example, the fingers 4602 may extend into or around the gaps or compartments depicted in the stabilizing structures of fig. 29A-39B. The fingers 4602 may also extend around the outside of the perimeter of the stabilizing structure. In some embodiments, the fingers 4602 from one foam layer 4600 may extend through the inner or outer circumference of the stabilization structure, merging with the fingers 4602 from a second foam layer 4600.

In some embodiments, the foam layer 4600 may have perforations or pre-cuts to allow for easy tearing off of portions of the foam layer 4600 in order to shape the foam for a particular wound. In some embodiments, the fingers 4602 may extend at least about 1 mm from the surface of the foam layer, at least about 3 mm from the surface of the foam layer, at least about 5 mm from the surface of the foam layer, at least about 7.5 mm from the surface of the foam layer, at least about 10 mm from the surface of the foam layer, at least about 12.5 mm from the surface of the foam layer, at least about 25 mm from the surface of the foam layer, at least about 17.5 mm from the surface of the foam layer, at least about 20 mm from the surface of the foam layer, at least about 25 mm from the surface of the foam layer, or greater than 25 mm.

Fig. 41 is a photograph of a non-limiting experiment involving an embodiment of the stabilizing structure 4700 illustrated in the previous examples, particularly the embodiments illustrated in fig. 29A-C and fig. 36A-F. In this non-limiting experiment, the stabilization construct was inserted into a cadaver wound, then sealed with a drape, and connected to a negative pressure source, as previously described.

In other embodiments, the edges of the stabilizing structure are rounded to more closely fit within the shape of the wound. The stabilization structure may be cut or bent into a desired shape. For example, the stabilizing structure may be manufactured in an elliptical shape to better fit into a wound shaped like an ellipse. Also, as illustrated in this section or elsewhere in this specification, in some embodiments, the stabilizing structure may be provided with perforations or pre-formed cuts, allowing portions of the stabilizing structure to be torn off to form the desired shape.

Fig. 42A-C are photographs of embodiments of a stabilization structure 4200, the stabilization structure 4200 being similar to those embodiments of stabilization structures described with respect to fig. 36A-39B, further including a foam insert 4800. Insert 4800 can be constructed from any of the materials described in this section or elsewhere in this specification, including flexible, semi-rigid, and rigid foams, as well as other porous or compressible materials. The stiffness of foam insert 4800 may be used to control collapse of stabilization structure 4200. For example, a harder foam may hinder the collapse of the stabilization structure 4200, while a flexible foam may allow the stabilization structure to collapse faster and more easily. By varying the flexibility/stiffness of the foam, the structure is allowed to collapse at any rate, as explained in this section or elsewhere in this specification. In some embodiments, the overall density of the stabilizing structure and/or wound closure device may be altered by increasing or decreasing the amount of foam within structure 4200. By reducing the overall density, the structure will be able to collapse more easily. Thus, using a less dense structure with less foam may allow the wound to close to a greater degree because such a structure may collapse more easily. Conversely, a more dense structure, with more foam, may be less collapsible. In other embodiments, the foam insert comprises only a portion of each compartment 4210.

In some embodiments, these foams may be configured to degrade or dissolve over time, allowing the foam insert to initially hold the stabilizing structure open, and then degrade or dissolve in a controlled manner to control the rate of collapse of the stabilizing structure. In further embodiments, the foam insert may be impregnated with a bioactive material that promotes wound healing. For example, the bioactive material may be an anti-inflammatory molecule, a growth factor, or an antimicrobial material.

Fig. 42A is a photographic perspective view of a stabilization structure 4200 in an open state, wherein a compartment 4210 that does not contain foam is not collapsed. Fig. 42B is a photograph of the top of the stabilization structure 4200 with the compartment 4210 in a collapsed state. Fig. 42C is a photograph of a top view of stabilization structure 4200 with alternate cells in some rows having foam inserts 4800 or no foam inserts 4210. In some embodiments, the foam insert may be inserted into at least about 5% of the cells, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100% of the cells.

Fig. 43 illustrates an embodiment of a ring 4800, which may enclose a stabilizing structure illustrated in this section or elsewhere in this specification. The loop 4800 can include a layer of tissue anchors 4802 configured to grip the peripheral edge of the wound. For example, these tissue anchors may be hooks, barbs, tines, or other structures, such as those described with respect to fig. 3A-D, for attachment to the tissue of a wound. In some embodiments, the tissue anchor comprises a hook and loop fastener, such as the hook and loop fasteners used in Velcro (Velcro) technology. In certain embodiments, the ring 4800 can be constructed of foam, such as the foam described previously, or the ring can be constructed of a combination of a foam layer and a tissue anchoring layer 4802. Lip 4804 may extend inwardly from ring 4800 and serve to overlap the top and/or bottom of the stabilization structure described in this section or elsewhere in this specification, thereby securing ring 4800 around the stabilization structure.

Fig. 44 is a photograph of a wound closure device 4900, the wound closure device 4900 including a stabilization structure 4902 such as the stabilization structures illustrated in this section or elsewhere in this specification, a foam layer 4904 such as the foam layer illustrated in this section or elsewhere in this specification, and a loop 4906 including tissue anchors similar to the loop depicted in fig. 43. In some embodiments, the wound closure device 4900 may be placed in a wound and sealed with a drape. Similar to the embodiment illustrated in fig. 29A-C and 36A-F, the stabilizing structure 4902 may collapse in any manner described in this section or elsewhere in this specification.

The stabilizing structures and/or wound closure devices described in this section or elsewhere in this specification may be used in conjunction with methods or systems for closing a wound. In some embodiments of methods of use to close a wound, one or more of the stabilizing structures or wound closure devices of any of the embodiments described in this section or elsewhere in this specification are placed into the wound. In some embodiments, an organ protective layer may be provided in the wound prior to placement of the stabilizing structure. In certain embodiments, foam or other porous material may be placed in the wound with the stabilizing structure or wound closure device, below, above, or around the stabilizing structure or wound closure device. Foam or other porous material may also surround the perimeter of the stabilizing structure or wound closure device. The stabilizing structure or wound closure device may be configured to collapse in any manner described in this section or elsewhere in this specification, such as by having a particular size and shape, or by including a volume of foam or other porous material inside the compartments of the structure. The stabilizing structure or wound closure device may be further modified in any manner described in this section or elsewhere in this specification to better accommodate the shape of the wound. After placement in the wound, the stabilizing structure or wound closure device may be sealed by a fluid-tight drape. The fluid-tight drape may include a port configured to apply a negative pressure. A source of negative pressure may then be connected to the port, and negative pressure may be applied to the wound. If desired, the stabilizing structure or wound closure device may be replaced over time with various shapes and sizes of stabilizing structures or wound closure devices to best promote wound healing.

Features, materials, characteristics or groups described in connection with a particular aspect, embodiment or example should be understood to apply to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible with each other. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The scope of protection is not limited to the details of any of the foregoing embodiments. The scope of protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection. Indeed, the novel methods and systems described in this section or elsewhere in this specification may be embodied in many other forms. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described in this section or elsewhere in this specification can be made. Those of skill in the art will appreciate that in some embodiments, the actual steps employed in the illustrated and/or disclosed processes may differ from those shown in the figures. Depending on the embodiment, some of the steps described above may be removed, and other steps may be added. Furthermore, the features and attributes of the specific embodiments disclosed above can be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure.

While the present disclosure includes certain embodiments, examples, and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and obvious modifications and equivalents thereof, including embodiments that do not provide all of the features and advantages set forth in this section or elsewhere in this specification. Accordingly, the scope of the disclosure is not intended to be limited by the specific disclosure of the preferred embodiments in this section or elsewhere in this specification, and may be defined by the claims presented or presented elsewhere in this section or this specification in the future.

Claims

1. A stabilizing structure for insertion into a wound, the stabilizing structure remaining substantially rigid or non-collapsing when a force is applied to the stabilizing structure in a vertical direction, the stabilizing structure comprising:

a plurality of compartments arranged side-by-side in a plane, each compartment being defined by one or more walls, each compartment having a top end and a bottom end, an opening extending through the top and bottom ends in a direction perpendicular to the plane;

wherein the stabilizing structure is configured to collapse more significantly within the plane than along a direction perpendicular to the plane;

wherein the compartment is more collapsible in a first direction along the plane than in a second direction along the same plane at an angle to the first direction;

wherein the material of the stabilizing structure is substantially rigid in a vertical direction such that the stabilizing structure does not substantially collapse when a weight is placed on the stabilizing structure.

2. The stabilizing structure of claim 1, wherein the stabilizing structure comprises a first plurality of strips extending in a first direction, and a second plurality of intersecting strips extending in a second direction perpendicular to the first direction, wherein the structure is collapsible in the first and second directions.

3. A stabilizing structure for insertion into a wound, the stabilizing structure remaining substantially rigid or non-collapsing when a force is applied to the stabilizing structure in a vertical direction, the stabilizing structure comprising:

a plurality of elongate strips arranged generally in parallel; and

a plurality of intervening members connecting the elongate strips, wherein the plurality of intervening members are configured to pivot relative to the plurality of elongate strips to allow the plurality of elongate strips to collapse relative to one another, the plurality of elongate strips and the plurality of intervening members defining a plurality of compartments of the stabilizing structure, the compartments being more collapsible in a first direction along a plane than in a second direction angled from the first direction along the same plane;

wherein the intervening member between a first strip and a second strip of the plurality of elongate strips is configured to pivot independently of the intervening member between a second strip and a third strip of the plurality of elongate strips;

4. The stabilizing structure of claim 3, wherein the intervening member is connected to the elongate strip via at least one joint.

5. The stabilizing structure of claim 4, wherein the joint is a hinge.

6. The stabilizing structure of claim 5, wherein the hinge is configured to collapse in one direction.

7. The stabilizing structure of claim 4, wherein the joint is configured to limit movement of the intervening member.

8. The stabilizing structure of any one of claims 3-7, wherein the elongate strips are rigid.

9. The stabilizing structure of any one of claims 3-7, wherein the stabilizing structure is configured such that 90% of the total collapse of any dimension occurs within one hour.

10. A stabilizing structure sized for insertion into a wound, the stabilizing structure remaining substantially rigid or non-collapsing when a force is applied to the stabilizing structure in a vertical direction, the stabilizing structure comprising:

wherein the at least one top and bottom straps are configured to be movably interlocked together by placing the indentations on the top strap over the indentations on the bottom strap to define a plurality of compartments of the stabilizing structure, and

wherein the compartments are configured to preferentially collapse along a first plane defined by the first and second directions while remaining movably interlocked and substantially non-collapsible along a third direction perpendicular to the first plane, and the compartments are more collapsible in a first direction along the first plane than in a second direction angled to the first direction along the same first plane;

11. The stabilizing structure of claim 10, wherein the at least one indent on the top strip and the at least one indent on the bottom strip are dimensioned such that, when movably interlocked together, the top strip does not extend substantially over the bottom strip in the third direction.

12. The stabilizing structure of claim 10 or 11, wherein the stabilizing structure comprises at least two top strips and at least two bottom strips so as to form at least one quadrilateral space bounded by the two top strips and the two bottom strips.

13. A stabilizing structure for insertion into a wound, the stabilizing structure remaining substantially rigid or non-collapsing when a force is applied to the stabilizing structure in a vertical direction, the stabilizing structure comprising:

at least one top strip extending in a first direction;

at least one bottom strip extending in a second direction;

wherein the at least one top strap and bottom strap are configured to be movably interlocked together using an interlocking mechanism to define a plurality of compartments of the stabilizing structure, and

14. The stabilizing structure of claim 13, wherein the interlocking mechanism comprises:

one of the at least one top strip or bottom strip comprising two parallel clasps extending in the third direction;

the other of the at least one top strip or bottom strip comprising a protrusion extending in the third direction; and is

Wherein the two parallel clasps are rotatably engaged with the protrusion so as to rotate about the protrusion in the first plane while remaining substantially stationary in the third direction.

15. The stabilizing structure of claim 13, wherein the interlocking mechanism comprises:

one of the top strip or the bottom strip comprising a tab having an enlarged distal end,

the other of the top strap or the bottom strap comprising a cup-shaped member configured to receive the enlarged distal end of the projection therein; and is

Wherein the top and bottom straps are rotatably engaged so as to rotate about the protrusion in the first plane without disengaging in the third direction.

16. The stabilizing structure of claim 13, wherein the interlocking mechanism comprises:

one of the at least one top strap or bottom strap comprising four clasps disposed at a perpendicular angle to each other extending in the third direction;

Wherein two parallel clasps are rotatably engaged with the protrusion so as to rotate about the protrusion in the first plane while remaining substantially stationary in the third direction.

17. A wound closure device, comprising:

a stabilizing structure that remains substantially rigid or does not collapse when a force is applied to the stabilizing structure in a vertical direction, the stabilizing structure comprising: a plurality of compartments arranged side-by-side in a plane, each compartment being defined by one or more walls, each compartment having a top end and a bottom end, an opening extending through the top and bottom ends in a direction perpendicular to the plane;

wherein the stabilizing structure is configured to collapse more significantly within the plane than along a direction perpendicular to the plane, the compartment being more collapsible in a first direction along the plane than in a second direction angled to the first direction along the same plane;

a separate foam layer disposed above, below, or both the upper and lower layers of the stabilizing structure, the foam layer including a plurality of fingers extending into the stabilizing structure; and

wherein the fingers are conical;

18. The wound closure device of claim 17, wherein the foam layer comprises a plurality of notches.

19. An apparatus for treating a wound with negative pressure wound therapy, comprising:

a stabilizing structure for insertion into or over a wound, the stabilizing structure remaining substantially rigid or non-collapsing when a force is applied to the stabilizing structure in a vertical direction, the stabilizing structure configured to collapse under negative pressure, the stabilizing structure having a length extending along a central longitudinal axis of the stabilizing structure, a width extending transverse to the length along a central transverse axis of the stabilizing structure, and a thickness transverse to the length and width, wherein the length and width are greater than the thickness, and wherein the stabilizing structure comprises:

a first side and a second side extending the length of the stabilizing structure, wherein the first side is opposite the second side, and wherein the first side and the second side are curved or bent outward relative to the central longitudinal axis to provide an at least partially elliptical shape to an outer perimeter of the stabilizing structure;

a plurality of elongate strips extending at least partially along a length of the stabilizing structure, wherein the plurality of elongate strips includes outermost elongate strips defining the first and second sides of the stabilizing structure, and a plurality of inner elongate strips positioned between the outermost elongate strips;

a plurality of intervening members connecting the elongate strips, wherein the plurality of intervening members are configured to pivot relative to the plurality of elongate strips to allow the plurality of elongate strips to collapse relative to one another; and

a plurality of compartments arranged side-by-side in a horizontal plane parallel to the length and width of the stabilizing structure, each compartment being defined by a plurality of walls extending in a vertical direction perpendicular to the horizontal plane and formed either by the elongate strip or by the intervening member, each compartment having a top end and a bottom end through which an opening extends;

wherein, by collapsing the plurality of compartments, the stabilizing structure is configured to collapse more in the horizontal plane than in the vertical direction, the compartments being more collapsible in a first direction along the horizontal plane than in a second direction along the same horizontal plane that is at an angle to the first direction;

20. A negative pressure wound closure system, comprising:

the stabilizing structure of claim 19;

a negative pressure source configured to be in fluid communication with the wound.